PROACTIV CLARIFYING NIGHT- salicylic acid cream

Proactiv Clarifying Night by

Drug Labeling and Warnings

Proactiv Clarifying Night by is a Otc medication manufactured, distributed, or labeled by Alchemee, 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 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, ethylhexyl palmitate, cetearyl alcohol, PPG-12/SMDI copolymer, cyclopentasiloxane, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, squalane, hexylene glycol, chamomilla recutita (matricaria) flower extract, aleurites moluccana seed oil, retinol, sodium ascorbate, tocopherol, retinyl palmitate, ascorbic acid, panthenol, sodium hyaluronate, PEG-180, PEG-75, cetyl PEG/PPG-10/1 dimethicone, caprylic/capric triglyceride, butylene glycol, dimethicone, polysorbate 60, glyceryl stearate, PEG-100 stearate, dicetyl phosphate, ceteth-10 phosphate, sodium hydroxide, phenoxyethanol, methylparaben, ethylparaben, propylparaben, fragrance

Questions or comments?

Within US 1-800-950-4695

SPL UNCLASSIFIED SECTION

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 - 75 mL Tube Box

proactiv®    

CLARIFYING
NIGHT
CREAM

2.5 FL. OZ. 75 mL

salicylic acid
acne medication

INGREDIENTS AND APPEARANCE

PROACTIV CLARIFYING NIGHT 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-030
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)
PPG-12/SMDI Copolymer (UNII: 1BK9DDD24E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (45000 mpa.s at 1%) (UNII: 86FQE96TZ4)
Squalane (UNII: GW89575KF9)
Hexylene Glycol (UNII: KEH0A3F75J)
Dihexadecyl Phosphate (UNII: 2V6E5WN99N)
Ceteth-10 Phosphate (UNII: 4E05O5N49G)
Chamomile (UNII: FGL3685T2X)
KUKUI NUT OIL (UNII: TP11QR7B8R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
Panthenol (UNII: WV9CM0O67Z)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
Dimethicone (UNII: 92RU3N3Y1O)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Tocopherol (UNII: R0ZB2556P8)
Retinol (UNII: G2SH0XKK91)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Sodium Ascorbate (UNII: S033EH8359)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
Butylene Glycol (UNII: 3XUS85K0RA)
Sodium Hydroxide (UNII: 55X04QC32I)
Polysorbate 60 (UNII: CAL22UVI4M)
Phenoxyethanol (UNII: HIE492ZZ3T)
Methylparaben (UNII: A2I8C7HI9T)
Ethylparaben (UNII: 14255EXE39)
Propylparaben (UNII: Z8IX2SC1OH)
Peg-100 Stearate (UNII: YD01N1999R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-030-00	1 in 1 BOX	06/01/2015
1		75 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	06/01/2015

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-030)