PROACTIV GENTLE FORMULA CLARIFYING DAY- salicylic acid lotion

Proactiv Gentle Formula Clarifying Day by

Drug Labeling and Warnings

Proactiv Gentle Formula Clarifying Day by is a Otc medication manufactured, distributed, or labeled by THE PROACTIV COMPANY LLC, VEE PAK, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• 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 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 area 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 to once a day or every other day.

Inactive Ingredients

Water, Cyclopentasiloxane, Dimethicone, PPG-12/SMDI Copolymer, Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer, Squalane, Glyceryl Stearate, PEG-100 Stearate, Hexylene Glycol, Cetearyl Alcohol, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Rosmarinus Officinalis (Rosemary) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Melaleuca Alternifolia (Tea Tree) Flower Leaf/Stem Extract, Retinyl Palmitate, Glycerin, Polysorbate 60, Propylene Glycol, Sodium Hydroxide, Phenoxyethanol, Chlorphenesin, Methylparaben, Benzoic Acid, Fragrance

PRINCIPAL DISPLAY PANEL - 60 mL Carton

proactiv®

Gentle Formula

clarifying
day lotion

A.M. 3

salicylic acid acne medication

2 FL. OZ. 60 mL

INGREDIENTS AND APPEARANCE

PROACTIV GENTLE FORMULA CLARIFYING DAY 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-052
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)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Dimethicone (UNII: 92RU3N3Y1O)
Squalane (UNII: GW89575KF9)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Peg-100 Stearate (UNII: YD01N1999R)
Hexylene Glycol (UNII: KEH0A3F75J)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Linoleamidopropyl Pg-dimonium Chloride Phosphate (UNII: 5Q87K461JO)
Rosemary (UNII: IJ67X351P9)
Matricaria Recutita (UNII: G0R4UBI2ZZ)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Glycerin (UNII: PDC6A3C0OX)
Polysorbate 60 (UNII: CAL22UVI4M)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Hydroxide (UNII: 55X04QC32I)
Phenoxyethanol (UNII: HIE492ZZ3T)
Chlorphenesin (UNII: I670DAL4SZ)
Methylparaben (UNII: A2I8C7HI9T)
Benzoic Acid (UNII: 8SKN0B0MIM)
Ppg-12/smdi Copolymer (UNII: 1BK9DDD24E)
Melaleuca Alternifolia Flowering Top (UNII: 5AZ4S6N66F)
Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) (UNII: 86FQE96TZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-052-00	1 in 1 BOX	12/01/2003
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	12/01/2003

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-052)