CURIST ACNE RELIEF- adapalene gel

Curist Acne Relief by

Drug Labeling and Warnings

Curist Acne Relief by is a Otc medication manufactured, distributed, or labeled by Little Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Adapalene USP 0.1% (retinoid)*

*read consumer information leaflet

PURPOSE

Purpose

Acne treatment

INDICATIONS & USAGE

Use

for the treatment of acne

WARNINGS

Warnings

For external use only

Do not use

• on damaged skin (cuts, abrasions eczema, sunburn)
• if you are allergic to adapalene or any of the ingredients in this product

If pregnant or breast-feeding, ask a doctor before use

When using this product

• limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors
• do not wax to remove hair in areas where the product has been applied
• during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that become severe
• irritation (redness, itching, dryness, burning) is more likely to occur:
  • in the first few weeks of use
  • if using more than one topical acne medication at a time
  • but irritation usually lessens with continued use of this product
• it may take up to 3 months of once daily use to see result
• avoid product contact eyes, lips, and month. If contact occurs immediately flush the area with water.
• wash hands after use

Stop use and ask a doctor if

• you become pregnant, or planning to become pregnant while using this product
• you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath)
• irritation become severe
• you see no improvement after 3 months of once daily use

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Adults and children 12 years of age and older:

• use once daily
• clean the skin gently and pat dry before applying the product
• cover the entire affected area with a thin layer. For example, if your acne in on the face, apply the product to the entire face.
• do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation.
• Children under 12 years of age: ask a doctor

STORAGE AND HANDLING

Other information

• store at room temperature 68º to 77ºF
• protect from freezing

INACTIVE INGREDIENT

Inactive ingredients carbomer homopolymer, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide

QUESTIONS

Questions? Call 1 (888) 721-7115

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*Read carton and enclosed consumer information leaflet before using this product. Keep this carton and consumer information leaflet.The contain important information.

Distributed by: Little Pharma, Inc.

New York, NY 10023 | Made in India

PRINCIPAL DISPLAY PANEL

curist

Acne Relief

Adapalene Gel, 0.1%

Acne Teatment

Once Daily Topical Retinoid*

Fragrance Free

Oil Free

NET WT 1.6 oz (45 g)

INGREDIENTS AND APPEARANCE

CURIST ACNE RELIEF 
adapalene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72559-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF)	ADAPALENE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLOXAMER 182 (UNII: JX0HIX6OAG)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72559-015-13	1 in 1 CARTON	08/15/2022
1		45 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 72559-015-17	2 in 1 PACKAGE, COMBINATION	06/21/2024
2		1 in 1 CARTON
2		45 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091314	08/15/2022

Labeler - Little Pharma, Inc. (074328189)