ADAPALENE- adapalene gel 
Stryke Club, Inc.

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Adapalene Gel USP 0 1 percent

Active ingredient

Agapalene USP 0.1% (retinoid)*

*read consumer information leaflet

Purpose

Acne treatment

Use

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

Pregnancy/Breastfeeding,

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 (1-800-222-1222) right away.

Directions

Adults and children 12 years of age and older:

Children under 12 years of age: ask a doctor

Other information

Inactive ingredients

carbomer homopolymer, edetate disodium, methylparabem, poloxamer 182, propylene glycol, purified water, sodium hydroxide

Questions or comments?

Call 415.294.0377

Principal Display Panel

ADAPALENE GEL USP, 0.1%

FDA-APPROVED | ONCE DAILY

TOPICAL RETINOID*

DERMATOLOGIST DEVELOPED

Previously available only by prescription

First FDA-Approved over-the-counter topical retinoid* for acne treatment

Keep this carton and consumer information leaflet. They contain important information.

*Read carton and enclosed consumer information leaflet before using this product.

Fragrance free and oil free

NET WT OZ (g)

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

Stryke Club, Inc.

Los Angeles, CA 90069

WWW.STRYKECLUB.COM

Product Label

Adapalene USP 0.1% (retinoid)* *read consumer information leaflet

STRYKE CLUB Adapalene Gel

ADAPALENE 
adapalene gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82034-888
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF) ADAPALENE1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82034-888-051 in 1 CARTON11/12/2021
115 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09131411/12/2021
Labeler - Stryke Club, Inc. (117541253)

Revised: 11/2021
Document Id: ed9313e0-6ccc-49a3-abec-b55128e5edbf
Set id: 337264c5-dafd-48b1-a0b7-c24dd6f91cf5
Version: 1
Effective Time: 20211117
 
Stryke Club, Inc.