Adapalene by P & L Development, LLC ADAPALENE gel

Adapalene by

Drug Labeling and Warnings

Adapalene by is a Otc medication manufactured, distributed, or labeled by P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Adapalene USP 0.1% (retinoid)*

*read consumer information leaflet

Purpose

Acne treatment

Use

• For the treatment of acne

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:

• 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

Other information

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

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

• Previously available only by prescription
• Once daily topical retinoid*
• Oil free
• fragrance free
• Dermatologist developed and tested

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

READYinCASE Acne Treatment

INGREDIENTS AND APPEARANCE

ADAPALENE 
adapalene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59726-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF)	ADAPALENE	1 mg  in 1 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: 59726-114-05	1 in 1 CARTON	11/30/2023
1		15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090962	11/30/2023

Labeler - P & L Development, LLC (800014821)