SOOLANTRA (Page 3 of 3)

PATIENT INFORMATION

SOOLANTRA® (SOO-LAWN-TRAH)
(ivermectin) cream

Important: SOOLANTRA cream is for use on the skin only (topical use). Do not use SOOLANTRA cream in your mouth, eyes, or vagina.

What is SOOLANTRA cream?
SOOLANTRA cream is a prescription medicine used on the skin (topical) to treat pimples and bumps (inflammatory lesions) caused by a condition called rosacea.
It is not known if SOOLANTRA cream is safe and effective in children.

Before using SOOLANTRA cream, tell your healthcare provider about all your medical conditions, including if you:

  • are pregnant or plan to become pregnant. It is not known if SOOLANTRA cream will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if SOOLANTRA cream passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use SOOLANTRA cream.

Tell your healthcare provider about all of the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use SOOLANTRA cream?
See the detailed “Instructions for Use” that comes with SOOLANTRA cream for information on how to apply SOOLANTRA cream.

  • Use SOOLANTRA cream exactly as your healthcare provider tells you to.
  • Apply SOOLANTRA cream to the affected areas of your face 1 time a day.
  • Avoid contact with your eyes and lips
  • if SOOLANTRA cream is accidentally swallowed (ingested), call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of SOOLANTRA cream?
The most common side effects of SOOLANTRA cream include skin burning sensation and skin irritation. These are not all of the possible side effects of SOOLANTRA cream.
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 SOOLANTRA cream?

  • Store SOOLANTRA cream at room temperature between 68°F to 77°F (20°C to 25°C).

Keep SOOLANTRA cream and all medicines out of the reach of children.

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

What are the ingredients in SOOLANTRA cream?
Active ingredient: ivermectin
Inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol.

Marketed by: Galderma Laboratories, L.P., Dallas, Texas 75201 USA
P52476-3
Made in Canada For more information about SOOLANTRA cream, call 1-866-735-4137.

This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 10/2022

Package Label — 45 g

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

NDC 0299-3823-45

soolantra®

(ivermectin) cream, 1%

NET WT. 45 g

Rx only

For Topical Use Only

Keep Out of Reach of Children

GALDERMA

Marketed by:
GALDERMA LABORATORIES, L.P.
Dallas, TX 75201 USA
Made in Canada
P53299-3 Rev: 07/22

Not for oral, ophthalmic, or intravaginal use.
To Open Tube: Push cap in and turn counterclockwise to remove cap.
Usual Dosage: Apply to the affected areas once daily. See package insert for complete prescribing information.
Each gram contains the active ingredient ivermectin 10 mg (1%) with the inactive ingredients carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol.
Storage: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).
(See USP Controlled Room Temperature).See carton closure for lot number and expiration.

SOOLANTRA ivermectin cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0299-3823
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVERMECTIN (IVERMECTIN) IVERMECTIN 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
CETYL ALCOHOL
CITRIC ACID MONOHYDRATE
DIMETHICONE
EDETATE DISODIUM
GLYCERIN
ISOPROPYL PALMITATE
METHYLPARABEN
OLEYL ALCOHOL
PHENOXYETHANOL
POLYOXYL 20 CETOSTEARYL ETHER
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM HYDROXIDE
SORBITAN MONOSTEARATE
STEARYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0299-3823-30 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (0299-3823-30)
2 NDC:0299-3823-45 1 TUBE in 1 CARTON contains a TUBE
2 45 g in 1 TUBE This package is contained within the CARTON (0299-3823-45)
3 NDC:0299-3823-60 1 TUBE in 1 CARTON contains a TUBE
3 60 g in 1 TUBE This package is contained within the CARTON (0299-3823-60)
4 NDC:0299-3823-02 1 TUBE in 1 BLISTER PACK contains a TUBE
4 2 g in 1 TUBE This package is contained within the BLISTER PACK (0299-3823-02)
5 NDC:0299-3823-00 2 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206255 01/01/2015
Labeler — Galderma Laboratories, L.P. (047350186)
Registrant — Galderma Laboratories, L.P. (047350186)
Establishment
Name Address ID/FEI Operations
G Production, Inc. 251676961 manufacture (0299-3823)

Revised: 10/2022 Galderma Laboratories, L.P.

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