Proactiv Solution Gentle Formula Clarifying Day Lotion

Proactiv by

Drug Labeling and Warnings

Proactiv by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV  GENTLE FORMULA CLARIFYING DAY- salicylic acid lotion 
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 Gentle Formula Clarifying Day Lotion

Drug Facts

Active Ingredient

Salicylic Acid 2%

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.

Stop use and ask a doctor if skin irritation occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Cleanse the skin thoroughly before applying medication.
  • Cover the entire affected area with a thin layer 1 to 3 times daily (A.M.)
  • 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.
  • If going outside, use a sunscreen.

Inactive Ingredients

water (aqua), cyclopentasiloxane, dimethicone, , linoleamidopropyl PG-dimonium chloride phosphate, PPG-12/SMDI copolymer, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, squalane, glyceryl stearate, PEG-100 stearate, rosmarinus officinalis (rosemary) leaf extract, melaleuca alternifolia (tea tree) extract, chamomilla recutita (matricaria) flower extract, retinyl palmitate, cetearyl alcohol, polysorbate 60, hexylene glycol, phenoxyethanol, chlorphenesin, glycerin, propylene glycol, methylparaben, benzoic acid, sodium hydroxide, fragrance (parfum)

PRINCIPAL DISPLAY PANEL - 60 mL Carton

Rodan & Fields

proactiv®
SOLUTION

Gentle Formula

Clarifying
Day Lotion

A.M. 3

non-comedogenic

salicylic acid acne treatment

2 FL. OZ. 60 mL

Principal Display Panel - 60 mL Bottle Carton
PROACTIV   GENTLE FORMULA CLARIFYING DAY
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11410-202
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: 11410-202-1030 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/200312/31/2019
2NDC: 11410-202-231 in 1 BOX12/01/200312/31/2019
260 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D12/01/200312/31/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 7/2010
Document Id: 5b77e10b-718e-4963-a1d7-d05ddb6c51cf
Set id: 8cf3999d-35b7-4db4-8623-5541c76de28c
Version: 4
Effective Time: 20100714
 
THE PROACTIV COMPANY LLC