proactiv® SOLUTION Deep Cleansing Wash

Proactiv by

Drug Labeling and Warnings

Proactiv by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV   DEEP CLEANSING WASH- salicylic acid cream 
THE PROACTIV COMPANY 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®
SOLUTION
Deep Cleansing
Wash

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

Use

For the management of acne

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product

• using other topical acne medications 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.
• avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• For face and body.
• Apply to dampened skin and gently massage.
• Rinse with warm water.
• Pat dry.
• If bothersome dryness or peeling occurs, reduce application use.

Inactive Ingredients

water (aqua), cocamidopropyl betaine, distearyl phthalic acid amide, polyethylene, cetyl alcohol, stearyl alcohol, jojoba esters, PEG-120 methyl glucose dioleate, ammonium laureth sulfate, camellia sinensis leaf extract, aloe barbadensis leaf juice, menthol, butylene glycol, sodium hydroxide, disodium EDTA, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum), chromium hydroxide green (CI 77289)

PRINCIPAL DISPLAY PANEL - 120 mL Label

Rodan & Fields

proacitv®
SOLUTION

Deep Cleansing
Wash

salicylic acid acne treatment

4 FL. OZ. 120 mL

PROACTIV   DEEP CLEANSING WASH
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-509
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	0.02 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-509-40	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2005	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/01/2005	01/01/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020

Document Id: 673bd112-69cb-4979-a819-3567bbcd6926

34390-5

Set id: 8fcefdc9-e9b3-4989-837b-0112b8f323b1

Version: 2

Effective Time: 20200114