proactiv® SOLUTION Clarifying Night Cream Salicylic Acid Acne Treatment Drug Facts

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]

PROACTIV  CLARIFYING NIGHT ACNE TREATMENT- salicylic acid cream 
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 Clarifying Night Cream
Salicylic Acid Acne Treatment

Drug Facts

Active Ingredient

Salicylic Acid 1%

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.
• avoid unnecessary sun exposure and use a sunscreen.

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), ethylhexyl palmitate, cetearyl alcohol, PPG-12/SMDI copolymer, cyclopentasiloxane, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, squalane, chamomilla recutita (matricaria) flower extract, aleurites moluccana seed oil, retinol, sodium ascorbate, tocopherol, retinyl palmitate, ascorbic acid, panthenol, sodium hyaluronate, PEG-180, PEG-75, PEG-8 cetyl dimethicone, hexylene glycol, caprylic/capric triglyceride, propylene glycol, dimethicone, polysorbate 60, glyceryl stearate, PEG-100 stearate, dicetyl phosphate, ceteth-10 phosphate, sodium hydroxide, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum)

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

Rodan & Fields

proactiv®
SOLUTION

CLARIFYING
NIGHT CREAM

non-comedogenic
helps to clear pores

salicylic acid acne treatment

1 FL. OZ. 30 mL

PROACTIV   CLARIFYING NIGHT ACNE TREATMENT
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-402
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)
Squalane (UNII: GW89575KF9)
Hexylene Glycol (UNII: KEH0A3F75J)
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)
Panthenol (UNII: WV9CM0O67Z)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Polyethylene Glycol 8000 (UNII: Q662QK8M3B)
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
Medium-chain Triglycerides (UNII: C9H2L21V7U)
Butylene Glycol (UNII: 3XUS85K0RA)
Dimethicone (UNII: 92RU3N3Y1O)
Polysorbate 60 (UNII: CAL22UVI4M)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Peg-100 Stearate (UNII: YD01N1999R)
Dihexadecyl Phosphate (UNII: 2V6E5WN99N)
Ceteth-10 Phosphate (UNII: 4E05O5N49G)
Sodium Hydroxide (UNII: 55X04QC32I)
Phenoxyethanol (UNII: HIE492ZZ3T)
Methylparaben (UNII: A2I8C7HI9T)
Ethylparaben (UNII: 14255EXE39)
Propylparaben (UNII: Z8IX2SC1OH)
Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) (UNII: 86FQE96TZ4)
Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) (UNII: V2W71V8T0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-402-28	1 in 1 BOX	01/01/2002	12/02/2019
1		75 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11410-402-29	1 in 1 BOX	01/01/2002	12/02/2019
2		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	01/01/2002	12/02/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-402)

Revised: 12/2019

Document Id: 93fbd4e4-5aba-44e3-94bf-b8483ac44f03

34390-5

Set id: fb365020-ac88-471b-812c-2ac2d79dcf53

Version: 3

Effective Time: 20191218

 

THE PROACTIV COMPANY LLC