ADAPALENE- adapalene gel 
P & L Development, LLC

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Adapalene Gel USP 0 1 percent ENE 0 5 OZ

Active ingredient

Adapalene 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:

Other information

Inactive ingredients

carbomer homopolymertype C, edetate disodium, methylparabem, poloxamer 182, propylene glycol, purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredient in  Differin® Gel

adapalene Gel USP, 0.1%

acne Treatment

net wt oz (g)

*Read consumer information leaflet before use

†This product is not manufactured or distributed by Galderma Laboratories, L.P. distributor of Differin® Gel.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

Product Label

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

READYinCASE Acne Treatment

ADAPALENE 
adapalene gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-114
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:59726-114-051 in 1 CARTON11/30/2023
115 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09096211/30/2023
Labeler - P & L Development, LLC (800014821)

Revised: 2/2024
Document Id: d223c233-be23-4ead-913c-52753e0e4df0
Set id: e9155950-6c92-4f57-851a-51be6ba9062f
Version: 2
Effective Time: 20240221
 
P & L Development, LLC