PROACTIV ACNE CLEARING BODY- salicylic acid spray

Proactiv Acne Clearing Body by

Drug Labeling and Warnings

Proactiv Acne Clearing Body by is a Otc medication manufactured, distributed, or labeled by The Proactiv Company, LLC, Topiderm Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

PROACTIV ACNE CLEARING BODY 
salicylic acid spray

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - The Proactiv Company, LLC (080216357)

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