Capex (Page 2 of 2)

ADVERSE REACTIONS:

The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: dryness, folliculitis, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, burning, itching, irritation and hypopigmentation.

OVERDOSAGE:

Topically applied Capex® Shampoo can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

DOSAGE AND ADMINISTRATION:

The pharmacist must empty the contents of the enclosed capsule into the shampoo base prior to dispensing to the patient. This product should be shaken well prior to use. No more than approximately one (1) ounce of the medicated shampoo should be applied to the scalp area once daily, worked into a lather and allowed to remain on the scalp for approximately 5 minutes. The hair and scalp should then be rinsed thoroughly with water.

HOW SUPPLIED:

Capex® Shampoo is supplied as a two component package: a capsule which contains the active component fluocinolone acetonide, and a separate package of liquid shampoo. The pharmacist must mix the content of the capsule into the base at the time of dispensing. Capex® Shampoo is dispensed to the patient in a 6 ounce bottle.

Shake well before using.

Store at controlled room temperature 68° — 77°F (20° — 25°C) with excursions permitted between 59° — 86°F (15° — 30°C) in tightly closed containers.

Marketed by:

GALDERMA LABORATORIES, L.P.

Fort Worth, Texas 76177 USA

Made in Canada.

P52306-3

GALDERMA is a registered trademark.

Revised: December 2015

PATIENT INFORMATION

Capex® (kap-eks) Shampoo
(fluocinolone acetonide)
Topical Shampoo, 0.01%

Important:

Capex Shampoo is for use on the skin only. Do not get Capex Shampoo in your eyes.

What is Capex Shampoo?

Capex Shampoo is a prescription medicine used on the scalp to treat a skin condition called seborrheic dermatitis. It is not known if Capex Shampoo is safe and effective in children and infants.

Who should not use Capex Shampoo?

Do not use Capex Shampoo if you are allergic to any of its ingredients. See the end of this leaflet for a complete list of ingredients in Capex Shampoo.

Before using Capex Shampoo, tell your doctor about all of your medical conditions, including if you:

• have a scalp infection. You may need medicine to treat the scalp infection before you use Capex Shampoo.
• are pregnant or plan to become pregnant. It is not known if Capex shampoo can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Capex Shampoo passes into your breast milk and if it can harm your baby. Talk to your doctor about the best way to feed you baby if you use Capex Shampoo.


Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. Do not use other products containing a corticosteroid medicine with Capex Shampoo without talking to your doctor first.

How should I use Capex Shampoo?

• When you receive your Capex Shampoo, it will already be mixed in a bottle by your pharmacist.
• Use Capex Shampoo exactly as your doctor tells you to use it.
• Your doctor should tell you how much Capex Shampoo to use and where to apply it.
• Capex Shampoo is for use on your scalp only (topical).
• Shake the Capex Shampoo bottle well before using.
• Do not apply more than 1 ounce of Capex Shampoo to your scalp, 1 time each day.
• Work Capex Shampoo into a lather.
Leave Capex Shampoo on your scalp for at least 5 minutes.
• Rinse your hair and scalp well with water.
• Avoid getting Capex Shampoo in your eyes. If you get Capex Shampoo in your eyes, rinse your eyes well with water.
Do not bandage or cover your head after using Capex Shampoo unless your doctor tells you to.
• Tell your doctor if you develop irritation where you apply Capex Shampoo, or if your seborrheic dermatitis is not getting better with Capex Shampoo.

What are the possible side effects of Capex Shampoo?

Capex Shampoo can pass through your skin.

The side effects of corticosteroids medicines used on the skin (topical) include:

• dry, itchy, and reddened skin

• burning or stinging at application site

• inflamed hair follicle

• acne

• thinning of skin

• loss of skin color

These are not all the possible side effects of Capex Shampoo. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Capex Shampoo?

• Store Capex Shampoo at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the Capex Shampoo bottle tightly closed.
• Throw away (discard) your Capex Shampoo bottle after 2 months, even if there is still medicine left in the bottle.

Keep Capex Shampoo and all medicines out of the reach of children.

General information about the safe and effective use of Capex Shampoo.

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

What are the ingredients in Capex Shampoo?

Active ingredient: fluocinolone acetonide
Inactive ingredients: aluminum acetate dibasic, benzalkonium chloride solution, boric acid, citric acid anhydrous, cocamido-ether-sulfate complex, cocoamine oxide, dibasic calcium phosphate dihydrate, lauramide DEA, magnesium aluminum silicate, methylparaben, oat flour, propylene glycol, propylparaben, purified water, talc, fragrances, D&C Yellow 10, and FD&C Blue 1 as coloring.

Marketed by: GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177, USA
GALDERMA is a registered trademark.

Made in CanadaP52306-3

This Patient Information has been approved by the U.S. Food and Drug Administration

Issued: 12/2015

PACKAGE LABEL

capex-shampoo-carton-image
(click image for full-size original)

ATTN PHARMACIST: Empty contents of enclosed capsule into shampoo bottle.

Rx only

NDC 0299-5500-04

Capex ®
(fluocinolone acetonide)
topical shampoo

SHAMPOO (as dispensed)

0.01%

For Topical Use Only
Shake Well Before Use
Discard Contents After Two Months

4 fl oz

GALDERMA

ATTN PHARMACIST: Empty contents of enclosed capsule into shampoo bottle.

Usual Dose: Apply no more than approximately one ounce of shampoo on affected area, let stand for 5 minutes, then rinse thoroughly with water.

See package insert for full prescribing information.

Marketed by:
GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USA

Made in Canada.

All trademarks are the property of their respective owners.

P52307-3

Contains: (As dispensed) Fluocinolone Acetonide (0.01%), dibasic calcium phosphate dihydrate USP, talc USP, in a shampoo base containing aluminum acetate dibasic, benzalkonium chloride solution, boric acid, citric acid anhydrous, cocamido-ether sulfate complex, cocoamine oxide, lauramide DEA, magnesium aluminum silicate, methylparaben, oat flour, propylene glycol, propylparaben, purified water and fragrance with D & C Yellow No. 10 and FD&C Blue No. 1 as coloring.

Storage: Keep tightly closed. Store at controlled room temperature 68° — 77°F (20° — 25°C) with excursions permitted between 59° — 86°F (15° — 30°C)

Contents: 4 fl oz in 6 oz bottle for convenience of Pharmacist.

For External Use Only.

Keep out of reach of children.

Warning: In case of eye contact rinse eye thoroughly with water.

CAPEX fluocinolone acetonide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0299-5500
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0299-5500-04 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 PACKAGE 12 mg
Part 2 1 BOTTLE 118 mL
Part 1 of 2
FLUOCINOLONE ACETONIDE fluocinolone acetonide powder, for solution
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE 1 mg in 1 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 12 mg in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020001 10/12/1984
Part 2 of 2
BASE shampoo shampoo
Product Information
Route of Administration TOPICAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
TALC
ALUMINUM ACETATE
BENZALKONIUM CHLORIDE
BORIC ACID
ANHYDROUS CITRIC ACID
COCO DIETHANOLAMIDE
COCAMINE OXIDE
LAURIC DIETHANOLAMIDE
MAGNESIUM ALUMINUM SILICATE
METHYLPARABEN
OATMEAL
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
D&C YELLOW NO. 10
FD&C BLUE NO. 1
Packaging
# Item Code Package Description Multilevel Packaging
1 118 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020001 10/12/1984
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020001 10/12/1984
Labeler — Galderma Laboratories, L.P. (047350186)
Establishment
Name Address ID/FEI Operations
Confab Laboratories 241754217 MANUFACTURE (0299-5500)

Revised: 06/2018 Galderma Laboratories, L.P.

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