PROACTIV GENTLE FORMULA CLEARIFYING NIGHT- salicylic acid lotion

Proactiv by

Drug Labeling and Warnings

Proactiv 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 1.0%

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 a 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 or 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, Ethylhexyl Palmitate, Cetearyl Alcohol, Cyclopentasiloxane, PPG-12/SMDI Copolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Hexylene Glycol, Dicetyl Phosphate, Ceteth-10 Phosphate, Chamomilla Recutita (Matricaria) Flower Extract,  Aleurites Moluccana Seed Oil, Retinol, Sodium Ascorbate, Tocopherol, Retinyl Palmitate, Ascorbic Acid, PEG-180, PEG-75, PEG-8 Cetyl Dimethicone, Panthenol, Sodium Hyaluronate, Caprylic/Capric Triglyceride, Propylene Glycol, Dimethicone, Polysorbate 60, Glyceryl Stearate, PEG-100 Stearate, Sodium Hydroxide, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben, fragrance

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 - 30 mL Carton

proactiv®

Gentle Formula

Clarifying
Night Lotion

P.M. 3

salicylic acid acne medication

1 FL. OZ. 30 mL

INGREDIENTS AND APPEARANCE

PROACTIV   GENTLE FORMULA CLEARIFYING NIGHT
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Ethylhexyl Palmitate (UNII: 2865993309)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Ppg-12/smdi Copolymer (UNII: 1BK9DDD24E)
Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) (UNII: 86FQE96TZ4)
Squalane (UNII: GW89575KF9)
Hexylene Glycol (UNII: KEH0A3F75J)
Dihexadecyl Phosphate (UNII: 2V6E5WN99N)
Ceteth-10 Phosphate (UNII: 4E05O5N49G)
Matricaria Recutita (UNII: G0R4UBI2ZZ)
Kukui Nut Oil (UNII: TP11QR7B8R)
Retinol (UNII: G2SH0XKK91)
Sodium Ascorbate (UNII: S033EH8359)
Tocopherol (UNII: R0ZB2556P8)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Polyethylene Glycol 8000 (UNII: Q662QK8M3B)
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
Panthenol (UNII: WV9CM0O67Z)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Medium-chain Triglycerides (UNII: C9H2L21V7U)
Propylene Glycol (UNII: 6DC9Q167V3)
Dimethicone (UNII: 92RU3N3Y1O)
Polysorbate 60 (UNII: CAL22UVI4M)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Phenoxyethanol (UNII: HIE492ZZ3T)
Methylparaben (UNII: A2I8C7HI9T)
Ethylparaben (UNII: 14255EXE39)
Butylparaben (UNII: 3QPI1U3FV8)
Propylparaben (UNII: Z8IX2SC1OH)
Isobutylparaben (UNII: 0QQJ25X58G)
Peg-8 Dimethicone (UNII: GIA7T764OD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-305-29	1 in 1 BOX	03/01/2008
1		30 mL in 1 TUBE; 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	03/01/2008

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-305)