Proactiv Solution Clear Zone Body 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 CLEAR ZONE- 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 Clear Zone Body Lotion

Drug Facts

Active Ingredient

Salicylic Acid 2.0%

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.
• Because excessive drying of the skin may occur, start with one 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), cyclopentasiloxane, dimethicone, 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, linoleamidopropyl PG-dimonium chloride phosphate, glycerin, cetearyl alcohol, polysorbate 60, propylene glycol, hexylene glycol, sodium hydroxide, phenoxyethanol, chlorphenesin, methylparaben, benzoic acid, fragrance (parfum)

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label

Rodan & Fields

proactiv®
SOLUTION

CLEAR ZONE®
BODY LOTION

non-comedogenic
for face and body

salicylic acid acne treatment

8 FL. OZ. 240 mL

PROACTIV  CLEAR ZONE
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-301-20	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2004	12/31/2019
2	NDC: 11410-301-40	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2004	12/31/2019
3	NDC: 11410-301-80	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2004	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	01/01/2004	12/31/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 7/2010

Document Id: 0b6368b1-c631-4dbd-b3e8-3f75027d162e

34390-5

Set id: 66ec8154-4108-4bfa-b025-e16eed632d81

Version: 2

Effective Time: 20100702

 

THE PROACTIV COMPANY LLC