PROACTIV BLACKHEAD DISSOLVING- salicylic acid gel

Proactiv Blackhead Dissolving by

Drug Labeling and Warnings

Proactiv Blackhead Dissolving by is a Otc medication manufactured, distributed, or labeled by THE PROACTIV COMPANY LLC, VEE PAK, LLC, KIK Holdco Company Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

DirectionsAs 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

SPL UNCLASSIFIED SECTION

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

Manfuactured in Canada
Proactiv is a trademark of the Proactiv Company Sàrl.

PRINCIPAL DISPLAY PANEL - 30 mL Tube Box

proactiv®

BLACKHEAD
DISSOLVING GEL

1 FL. OZ. 30 mL

salicylic acid acne medication

INGREDIENTS AND APPEARANCE

PROACTIV BLACKHEAD DISSOLVING 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-024
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)
Polyacrylamide (1300000 Mw) (UNII: SC5Y4X78TG)
Peg-80 Sorbitan Laurate (UNII: 239B50Y732)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-024-05	1 in 1 BOX	05/01/2013
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

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-024)

Establishment
Name	Address	ID/FEI	Business Operations
KIK Holdco Company Inc		243547333	manufacture(11410-024)