PROACTIV PLUS RETEXTURIZING TONER- salicylic acid cream
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.

----------

Proactiv Retexturizing Toner

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

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

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

Proactiv Retexturizing Toner 59 mL Carton

PRINCIPAL DISPLAY PANEL - 59 mL Carton (Pads)

proactiv ®

Re-Texturizing
Toner

2 FL. OZ. 59 mL

30 Pads

Proactiv Retexturizing Toner Pads 59 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Proactiv®

Re-Texturizing
Toner

6 FL. OZ. 180 mL

salicylic acid acne medication

Proactiv Retexturizing Toner 180mL Bottle
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)

Revised: 7/2018
Document Id: 21eed5a1-4d18-45ac-8241-93c75f463809
Set id: 7c211ff7-920f-407b-ad8d-60d14803b857
Version: 3
Effective Time: 20180710
THE PROACTIV COMPANY LLC