Proactiv® Solution Blackhead Dissolving Gel

Proactiv Solution Blackhead Dissolving by

Drug Labeling and Warnings

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

Drug Details [pdf]

PROACTIV SOLUTION BLACKHEAD DISSOLVING- 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 Blackhead Dissolving Gel

Drug Facts

Active ingredient

Salicylic Acid 0.5%

Purpose

Acne Treatment Gel

Use

for the management of acne.

Warnings

For external use only

When using this product

• skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
• avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor

If irritation becomes severe.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• cleanse the skin thoroughly before applying this product.
• cover the entire affected area with a thin layer and rinse thoroughly one to three times daily.
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
• if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredients

water, 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.

Questions or comments?

Within US 1-800-950-4695

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

PRINCIPAL DISPLAY PANEL - 30 mL Tube Box

Rodan & Fields

proactiv®
SOLUTION

BLACKHEAD
DISSOLVING GEL

removes impurities
shrinks pore appearance

salicylic acid acne treatment

1 FL. OZ. 30 mL

PROACTIV SOLUTION BLACKHEAD DISSOLVING 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-018
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 g  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)
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
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)
POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
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: 11410-018-29	1 in 1 BOX	05/01/2013	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	05/01/2013	12/31/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 4/2013

Document Id: cf928899-3c71-4056-b5df-2870bd9654bd

34390-5

Set id: fc02efce-d988-4ea0-99ae-3e9461a8ac13

Version: 3

Effective Time: 20130430

 

THE PROACTIV COMPANY LLC