Proactiv Solution Revitalizing Toner Salicylic Acid Acne Treatment

Proactiv Revitalizing Toner Combination Therapy Acne Treatment by

Drug Labeling and Warnings

Proactiv Revitalizing Toner Combination Therapy Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV REVITALIZING TONER COMBINATION THERAPY ACNE TREATMENT- salicylic acid liquid 
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 Revitalizing Toner
Salicylic Acid Acne Treatment

Active Ingredient

Salicylic Acid 2%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Purpose

Acne Treatment

Use

For the management of acne

Warnings

For external use only

When using this product

  • using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Directions

  • Cleanse the skin thoroughly before applying medication.
  • Using a cotton ball or pad, cover the entire affected area 1 to 3 times daily.
  • Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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 (aqua), butylene glycol, hamamelis virginiana (witch hazel) water, glycolic acid, sodium hydroxide, portulaca oleracea extract, polysorbate 20, ethylhexylglycerin, disodium EDTA, phenoxyethanol, sodium benzoate, fragrance (parfum)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

Rodan & Fields

proactiv®
SOLUTION

2
REVITALIZING
TONER

COMBINATION
THERAPY®

salicylic acid acne treatment

1 FL. OZ. 30 mL

Principal Display Panel - 30 mL Bottle Label
PROACTIV REVITALIZING TONER COMBINATION THERAPY ACNE TREATMENT 
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11410-019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11410-019-1030 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/201012/02/2019
2NDC: 11410-019-2060 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/201012/02/2019
3NDC: 11410-019-40120 mL in 1 BOTTLE; Type 0: Not a Combination Product08/02/201012/02/2019
4NDC: 11410-019-70180 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/201012/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D08/01/201012/02/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020
Document Id: 201a9b5a-f499-4457-87b9-830caf7cde81
Set id: 19618703-694d-4568-90b1-63d0e4ca07aa
Version: 2
Effective Time: 20200106
 
THE PROACTIV COMPANY LLC