Proactiv® Blackhead Dissolving Gel

Drug Labeling and Warnings

Drug Details [pdf]

PROACTIV 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® Blackhead Dissolving Gel

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

• 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

As a mask:

• Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 uses. If no discomfort occurs, follow the directions stated below.
• Apply 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 warm water. Pat dry. Use 1 – 2 times per week.
• If using with other acne products, limit to 1 time per week.
• If bothersome dryness or peeling occurs, reduce frequency of application.

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

Distributed by The Proactiv Company, LLC.
100 N Sepulveda Blvd., El Segundo, CA 90245

PRINCIPAL DISPLAY PANEL - 30 mL Tube Box

proactiv®

BLACKHEAD
DISSOLVING
GEL

1 FL. OZ. 30 mL

salicylic acid acne medication

PROACTIV BLACKHEAD DISSOLVING 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-014
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)
PEG-80 SORBITAN LAURATE (UNII: 239B50Y732)
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
SODIUM ACRYLATE (UNII: 7C98FKB43H)
PANTHENOL (UNII: WV9CM0O67Z)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEA BUTTER (UNII: K49155WL9Y)
LEVOMENOL (UNII: 24WE03BX2T)
LACTIC ACID, UNSPECIFIED FORM (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: 11410-014-29	1 in 1 BOX	03/08/2017	05/21/2019
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	03/08/2017	05/21/2019

Labeler - The Proactiv Company, LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 3/2017

Document Id: 1a681a50-9b23-44a1-a60d-95ee52458291

34390-5

Set id: 648ac05a-b626-4e85-a5d9-a90276ce6cc6

Version: 2

Effective Time: 20170310