PROACTIV PLUS RETEXTURIZING TONER- salicylic acid cream

Proactiv Plus Retexturizing Toner by

Drug Labeling and Warnings

Proactiv Plus Retexturizing Toner by is a Otc medication manufactured, distributed, or labeled by Alchemee, LLC, kdc/one Chatsworth, Inc., Vee Pak Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Salicylic Acid 2%

Purpose

Acne Treatment

Use

for the management of acne

Warnings

For external use only

When using this product

• do not use this product more than three times per day.
• 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

• Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days.  If no discomfort occurs, follow the directions stated below.
• cleanse the skin thoroughly before applying this product.
• cover the entire affected areas with a thin layer 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 use to once a day or every other day.

Inactive ingredients

water, butylene glycol, hamamelis virginiana (witch hazel) water, glycolic acid, sodium hydroxide, portulaca oleracea extract, ethylhexylglycerin, polysorbate 20, disodium EDTA, sodium benzoate, phenoxyethanol

Questions or comments?

Within US 1-800-950-4695

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Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245
proactiv.com ● Made in the USA of Foreign and Domestic Components
Proactiv is a trademark of The Proactiv Company Sàrl.

PRINCIPAL DISPLAY PANEL - 59 mL Carton

proactiv®

RE-TEXTURIZING
TONER                 

2 FL. OZ. 59 mL

salicylic acid acne medication

PRINCIPAL DISPLAY PANEL - 59 mL Carton (Pads)

proactiv®

Re-Texturizing
Toner

2 FL. OZ. 59 mL

30 Pads

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Proactiv®

Re-Texturizing
Toner

6 FL. OZ. 180 mL

salicylic acid acne medication 

INGREDIENTS AND APPEARANCE

PROACTIV PLUS RETEXTURIZING TONER 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
GLYCOLIC ACID (UNII: 0WT12SX38S)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PURSLANE (UNII: M6S840WXG5)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-051-00	1 in 1 CARTON	02/15/2014
1		59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 11410-051-05	1 in 1 CARTON	02/15/2014
2		59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 11410-051-10	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	02/15/2014

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
Vee Pak Inc.		874763303	MANUFACTURE(11410-051)