PROACTIV MD ADAPALENE ACNE TREATMENT- adapalene gel

Proactiv MD Adapalene by

Drug Labeling and Warnings

Proactiv MD Adapalene by is a Otc medication manufactured, distributed, or labeled by Alchemee, LLC, G Production Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Adapalene 0.1% (retinoid)1

1 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.

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:

• 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 is 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 room temperature 68°- 77°F
• protect from freezing

Inactive ingredients

carbomer 940, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide. May contain hydrochloric acid to adjust pH.

Questions?

1-866-735-4137

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Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245

PRINCIPAL DISPLAY PANEL - 15 g Tube Box

proactiv MD®

ADAPALENE GEL 0.1%
ACNE TREATMENT

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 0.5 OZ (15 g)

INGREDIENTS AND APPEARANCE

PROACTIV MD ADAPALENE   ACNE TREATMENT
adapalene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-956
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: 11410-956-44	1 in 1 BOX	03/27/2017
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11410-956-17	1 in 1 BOX	03/27/2017
2		45 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11410-956-38	1 in 1 BLISTER PACK	08/09/2017
3		2 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
NDA AUTHORIZED GENERIC	NDA020380	03/27/2017

Labeler - The Proactiv Company, LLC (080216357)