PROACTIV ACNE CLEARING BODY- salicylic acid spray
Alchemee, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Proactiv® Acne Clearing Body Spray

Drug Facts

Active ingredient

Salicylic acid 2%

Purpose

Acne treatment

Uses

for the management of acne of the body, with the skin enhancement properties of glycolic acid

Warnings

For external use only

Direct spray away from face, especially eyes, lips, and mouth
If irritation develops, discontinue use and consult a doctor.
Using other topical acne medication at the same time or immediately following use of this product may increase dryness or irritation of the skin. if this occurs, only one medication should be used unless directed by a doctor.

Keep out of reach of children

If swallowed, seek professional assistance or contact a Poison Control Center immediately.
Flammable; keep tightly closed, away from flame and heat.
Sunscreen use is recommended with any glycolic acid product and for an additional week thereafter, because some individuals may be more sensitive to sunlight.

Directions

Spray the entire affected area of the body one to three times daily.
Because excessive drying of the skin can occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a physician.
If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredients

water, glycolic acid, ethyl alcohol, ammonium hydroxide, hamamelis virginiana (witch hazel) water, acetone, polysorbate 20, sodium benzoate, imidazolidinyl urea, disodium EDTA, benzoic acid

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

Made in USA of Foreign and Domestic Components
Within USA 1-800-950-4695
proactive.com
Proactiv is a trademark of The Proactiv Company Sàrl

PA.LAB872

PRINCIPAL DISPLAY PANEL

proactiv®

ACNE
CLEARING
BODY SPRAY

3 FL. OZ. 89 mL

salicylic acid acne medication

PROACTIV ACNE CLEARING BODY
salicylic acid spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11410-061
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	2 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Glycolic Acid (UNII: 0WT12SX38S)
Alcohol (UNII: 3K9958V90M)
Ammonia (UNII: 5138Q19F1X)
Hamamelis Virginiana Top Water (UNII: NT00Y05A2V)
Acetone (UNII: 1364PS73AF)
Polysorbate 20 (UNII: 7T1F30V5YH)
Sodium Benzoate (UNII: OJ245FE5EU)
Imidurea (UNII: M629807ATL)
Edetate Disodium (UNII: 7FLD91C86K)
Benzoic Acid (UNII: 8SKN0B0MIM)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11410-061-32	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2017	07/07/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	06/28/2017	07/07/2019

Labeler - Alchemee, LLC (080216357)

Name	Address	ID/FEI	Business Operations
Establishment
Topiderm Inc.		049121643	manufacture(11410-061)

Revised: 12/2022

Document Id: 6e4a4b4d-d8d6-44e9-b2d3-4011bf62f609

Set id: 7fd00a12-b3e6-4d70-bc02-d3c63ec91d0b

Version: 2

Effective Time: 20221215

Alchemee, LLC