PROACTIV MD ADAPALENE ACNE TREATMENT- adapalene gel 
Alchemee, LLC

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Proactiv MD ®Adapalene Gel 0.1%
Acne Treatment

Drug Facts

Active ingredient

Adapalene 0.1% (retinoid) 1


1
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.

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 becomes 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 results
  • avoid product contact with eyes, lips, and mouth. If contact occurs, immediately flush the area with water.
  • wash hands after use

Stop use and ask a doctor if

  • you become pregnant, or are planning to become pregnant, while using the product
  • you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath)
  • irritation becomes 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.

Directions

Adults and children 12 years of age and older:

Children under 12 years of age: ask a doctor

Other information

Inactive ingredients

carbomer, disodium EDTA, phenoxyethanol, poloxamer 182, propylene glycol, sodium hydrixide, water

Distributed by Alchemee LLC,
Hawthorne, NY 10532

Made in Canada of Foreign

and Domestic Components

Questions?

1-800-950-4695

PRINCIPAL DISPLAY PANEL - 45 g Tube Box

proactivMD ®

ADAPALENE GEL 0.1%
ACNE TREATMENT

PARABEN-FREE

First FDA-Approved
Over-the-Counter
Topical Retinoid* for
Acne Treatment

Previously Available
Only By Prescription

Dermatologist
Developed and Tested

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

NET WT 1.6 OZ (45 g)

image 1

PROACTIV MD ADAPALENE  ACNE TREATMENT
adapalene gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-958
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF) ADAPALENE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLOXAMER 182 (UNII: JX0HIX6OAG)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-958-451 in 1 BOX11/16/2023
145 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11410-958-151 in 1 BOX11/16/2023
215 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21594011/16/2023
Labeler - Alchemee, LLC (080216357)
Registrant - Alchemee, LLC (080216357)

Revised: 11/2023
Document Id: 0a9b37b5-e067-4805-e063-6294a90ad703
Set id: 0a9b3755-c0db-4282-e063-6394a90a0c08
Version: 1
Effective Time: 20231116
 
Alchemee, LLC