Proactiv® Solution Purifying Botanical Peel

Proactiv Solution by

Drug Labeling and Warnings

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

Drug Details [pdf]

PROACTIV SOLUTION  PURIFYING BOTANICAL PEEL- salicylic acid gel 
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 Purifying Botanical Peel

Drug Facts

Active Ingredient

Salicylic Acid 0.5%

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.

Stop use and ask a doctor if skin irritation occurs.

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

Directions

• apply generously over clean face and neck
• massage with light circular movements until the gel liquefies on contact with the skin
• leave on for up to five minutes
• rinse thoroughly with water
• pat dry
• use once or twice per week, or as needed.

Inactive Ingredients

water (aqua), dimethicone, cyclopentasiloxane, glycereth-26, glycerin, cyclohexasiloxane, PEG-80 sorbitan laurate, dimethiconol, polyacrylate-13, panthenol, camellia sinensis leaf extract, aloe barbadensis leaf juice, butyrospermum parkii (shea) butter, bisabolol, lactic acid, caprylyl glycol, ethylhexylglycerin, PEG-40 hydrogenated castor oil, polyisobutene, hexylene glycol, polysorbate 20, PPG-26-buteth-26, butyl methoxydibenzoylmethane, ethylhexyl methoxycinnamate, ethylhexyl salicylate, phenoxyethanol, fragrance (parfum).

Dist. by Guthy-Renker®
PO Box 14383
Palm Desert, CA 92255-4383

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

Rodan & Fields

proactiv®
SOLUTION

PURIFYING
BOTANICAL PEEL

non-irritating
dermatologist tested

salicylic acid acne treatment

1 FL. OZ. 30 mL

PROACTIV SOLUTION  PURIFYING BOTANICAL PEEL
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-610
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERETH-26 (UNII: NNE56F2N14)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PANTHENOL (UNII: WV9CM0O67Z)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEA BUTTER (UNII: K49155WL9Y)
LEVOMENOL (UNII: 24WE03BX2T)
LACTIC ACID (UNII: 33X04XA5AT)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
AVOBENZONE (UNII: G63QQF2NOX)
OCTINOXATE (UNII: 4Y5P7MUD51)
OCTISALATE (UNII: 4X49Y0596W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-610-29	1 in 1 BOX	02/10/2012	12/31/2019
1		30 mL in 1 TUBE; 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	02/10/2012	12/31/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 2/2012

Document Id: bd20c55c-2616-4026-81ae-a1f9128ab487

34390-5

Set id: df6a1ce2-3c85-41c3-8dbf-2e9f99a780e3

Version: 2

Effective Time: 20120228