Proactiv Solution Deep Cleansing Wash

Proactiv Solution Deep Cleansing Wash by

Drug Labeling and Warnings

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

Drug Details [pdf]

PROACTIV SOLUTION DEEP CLEANSING WASH- salicylic acid lotion/shampoo 
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

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 thoroughly with warm water.
• Pat dry.
• If bothersome dryness or peeling occurs, reduce application use.

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label

Rodan & Fields
proactiv®
SOLUTION

DEEP CLEANSING
WASH

non-comedogenic
for face and body

salicylic acid acne treatment

8 FL. OZ. 240 mL

PROACTIV SOLUTION DEEP CLEANSING WASH 
salicylic acid lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-113
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: 11410-113-20	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2010	01/01/2019
2	NDC: 11410-113-40	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2010	01/01/2019
3	NDC: 11410-113-16	475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2010	01/01/2019
4	NDC: 11410-113-18	720 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2010	01/01/2019
5	NDC: 11410-113-81	1 in 1 BOX	10/01/2010	01/01/2019
5	NDC: 11410-113-80	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	10/01/2010	01/01/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020

Document Id: 8d0885ae-aac0-4c23-bff0-467ce058cb58

34390-5

Set id: 8df3fe18-0d91-47aa-a381-837c7d811f74

Version: 4

Effective Time: 20200108

 

THE PROACTIV COMPANY LLC