AKLIEF (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

AKLIEF Cream, 0.005% is provided as a white cream supplied in the following packaging configurations with corresponding NDC numbers:

  • 30-gram pump NDC 0299-5935-30
  • 45-gram pump NDC 0299-5935-45
  • 75-gram pump NDC 0299-5935-75

Storage and Handling
– Store at 20˚ to 25˚C (68˚ to 77˚F); excursions permitted to 15° to 30°C (59° to 86°F)..
– Keep away from heat.
– Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information).

Advise the patient to:

  • Cleanse the area to be treated; pat dry. Apply AKLIEF Cream as a thin layer once daily in the evening to the face, avoiding the eyes, lips, nasolabial folds, and mucous membranes. A thin layer of AKLIEF Cream may also be applied to the chest, shoulders, and back.
  • Avoid applying AKLIEF Cream to damaged skin (such as cuts, abrasions), eczematous areas, and sunburned skin.
  • Reduce the risk of such irritation, use a moisturizer from the start of treatment, and, if appropriate, reduce the frequency of application of AKLIEF Cream or suspend use temporarily. AKLIEF Cream may cause irritation such as erythema, scaling, dryness, and stinging or burning.
  • Minimize exposure to sunlight, including sunlamps and phototherapy devices.
  • Use sunscreen products and protective apparel (e.g., hat) over treated areas when exposure to sunlight cannot be avoided.
  • Avoid concomitant use of other potentially irritating topical products (medicated or not).
  • Use AKLIEF Cream on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply AKLIEF Cream directly to the nipple and areola to avoid direct infant exposure.


Marketed by:
GALDERMA LABORATORIES, L.P.
Dallas, Texas 75201 USA

Made in Canada
GALDERMA is a registered trademark.

Patient Information
AKLIEF® (trifarotene) cream

Important: AKLIEF Cream is for use on the skin only. Do not use AKLIEF Cream in your mouth eyes, or vagina.

What is AKLIEF Cream?
AKLIEF Cream is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 9 years of age and older.
It is not known if AKLIEF Cream is safe and effective in children younger than 9 years old.

Before using AKLIEF Cream, tell your healthcare provider about all of your medical conditions, including if you :

  • have skin problems, including eczema, cuts or sunburn
  • are pregnant or planning to become pregnant. It is not known if AKLIEF Cream can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if AKLIEF Cream passes into your breast milk. Breastfeeding women should use AKLIEF Cream on the smallest area of skin and for the shortest time needed while breastfeeding.
    Do not apply AKIEF Cream to the nipple and areola to avoid contact with your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-couter medicines, vitamins and herbal supplements.
Especially tell your healthcare provider if you use any other medicine for acne.

How should I use AKLIEF Cream?

  • Use AKLIEF Cream exactly as your healthcare provider tell you to use it. Apply a thin layer of AKLIEF Cream over the affected areas 1 time each day, in the evening.

Applying AKLIEF Cream:

  • Wash the area where the cream will be applied and pat dry.

  • If you receive a sample tube of AKLIEF Cream, follow your healthcare provider’s instructions about how much to apply.
  • AKLIEF Cream comes in a pump.
    • Press down on (depress) the pump 1 time to dispense a small amount of AKLIEF Cream and spread a thin layer over your face (forehead, cheeks, nose, and chin). Avoid contact with your eyes, lips, mouth, and the corners of your nose.
    • Press down on the pump 2 times to dispense enough AKLIEF Cream to apply a thin layer to cover your upper trunk (the area of your upper back that you can reach, shoulders, and chest). One more pump may be used to apply a thin layer of AKLIEF Cream to your middle and lower back, if acne is present.
  • When you begin treatment with AKLIEF Cream, you should begin applying a moisturizer on your skin as often as needed. See “Local skin irritation” below.

What should I avoid while using AKLIEF Cream?

  • Minimize exposure to sunlight. You should avoid using sunlamps, tanning beds, and ultraviolet light during treatment with AKLIEF Cream. If you have to be in sunlight or are sensitive to sunlight, use a sunscreen with a SPF (sun protection factor) of 15 or more, and wear protective clothing and a wide-brimmed hat to cover the treated areas.
  • Avoid using AKLIEF Cream on skin areas with cuts, abrasions, eczema, or on sunburned skin.
  • Avoid using skin products that may dry or irritate your skin, such as:
    • medicated or abrasive soaps and cleansers
    • soaps, cleansers, and cosmetics that have strong skin drying effects
    • products that contain high amounts of alcohol
  • Avoid the use of “waxing” as a hair removal method on skin treated with AKLIEF Cream.

What are the possible side effects of AKLIEF Cream?
AKLIEF Cream may cause serious side effects including:

  • Local skin irritation. Local skin reactions are common with AKLIEF Cream, are most likely to happen during the first 4 weeks of treatment and may decrease with continued use of AKLIEF Cream. Signs and symptoms of local skin reactions include:
    • redness
    • scaling
    • dryness
    • stinging or burning

To help reduce your risk of developing these local skin reactions, when you begin treatment with AKLIEF Cream, you should begin applying a moisturizer on your skin as often as needed.
Tell your healthcare provider if you develop symptoms of a local skin reaction. Your doctor may tell you to use AKLIEF Cream less often, or temporarily, or permanently stop your treatment with AKLIEF Cream.

The most common side effects of AKLIEF Cream include: itching and sunburn. See “What should I avoid while using AKLIEF Cream.
These are not all the possible side effects of AKLIEF Cream. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to GALDERMA LABORATORIES, L.P. at 1-866-735-4137.

How should I store AKLIEF Cream?

  • Store AKLIEF Cream at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F)
  • Keep AKLIEF Cream away from heat.
  • If you receive a sample tube of AKLIEF Cream from your healthcare provider, keep the tube tightly closed.

Keep AKLIEF Cream and all medicines out of the reach of children.

General information about the safe and effective use of AKLIEF Cream.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use AKLIEF Cream for a condition for which it was not prescribed. Do not give AKLIEF Cream to other people, even if they have the same symptoms you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about AKLIEF Cream that is written for health professionals.

What are the ingredients in AKLIEF Cream?
Active ingredient: trifarotene
Inactive ingredients: allantoin, copolymer of acrylamide and sodium acryloyldimethyltaurate dispersion 40% in isohexadecane, cyclomethicone, 95% (v/v) ethanol, medium-chain triglycerides, phenoxyethanol, propylene glycol, purified water.
Marketed by: GALDERMA LABORATORIES, L.P., Dallas, Texas 75201 USA
All trademarks are the property of their respective owners.
Made in Canada
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 01/2022
P54485-X

PACKAGE LABEL 45g CARTON

45-gram-carton-image
(click image for full-size original)

RX only NDC 0299-5935-45
AKLIEF
(trifarotene)
Cream, 0.005%
PUMP
For topical use only
NET WT.
45 g
GALDERMA

For topical use only
Not for oral, ophthalmic or intravaginal use
USUAL DOSAGE:
Apply a thin layer to affected areas of the face and / or trunk once a day. See package insert for complete prescribing information.
EACH GRAM CONTAINS:
Active: trifarotene 0.005%
Inactive: allantoin, copolymer of acrylamide and sodium acryloyldimethyltaurate dispersion 40% in isohexadecane, cyclomethicone, 95% (v/v) ethanol, medium-chain triglycerides, phenoxyethanol, propylene glycol, purified water. Contains 5% alcohol
STORAGE:
Store at a controlled room temperature of 20º to 25ºC (68º to 77ºF); excursions permitted between 15º and 30ºC (59º to 86ºF). See carton closure for lot number and expiration.

Marketed by:
GALDERMA LABORATORIES, L.P.
14501 North Freeway
Dallas, TX 75201 USA
Made in Canada
All trademarks are the property of their respective owners.
P54484-X
NET WT. 45 g

AKLIEF trifarotene cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0299-5935
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Trifarotene (Trifarotene) Trifarotene 50 ug in 1 g
Inactive Ingredients
Ingredient Name Strength
Allantoin
Acrylic Acid/Sodium Acrylate Copolymer (1:1; 600 Mpa.S At 0.2%)
Isohexadecane
Cyclomethicone 5
Alcohol
Medium-Chain Triglycerides
Phenoxyethanol
Propylene Glycol
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0299-5935-02 1 TUBE in 1 BLISTER PACK contains a TUBE
1 2 g in 1 TUBE This package is contained within the BLISTER PACK (0299-5935-02)
2 NDC:0299-5935-30 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
2 30 g in 1 BOTTLE, PUMP This package is contained within the CARTON (0299-5935-30)
3 NDC:0299-5935-45 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
3 45 g in 1 BOTTLE, PUMP This package is contained within the CARTON (0299-5935-45)
4 NDC:0299-5935-75 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
4 75 g in 1 BOTTLE, PUMP This package is contained within the CARTON (0299-5935-75)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA211527 10/04/2019
Labeler — Galderma Laboratories, L.P. (047350186)
Establishment
Name Address ID/FEI Operations
G Production Inc. 251676961 manufacture (0299-5935)

Revised: 07/2022 Galderma Laboratories, L.P.

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