Proactiv+ Clarifying Night Cream

Proactiv Plus Clarifying Night by

Drug Labeling and Warnings

Proactiv Plus Clarifying Night by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV PLUS CLARIFYING NIGHT- 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+ Clarifying Night Cream

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

• 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.
• 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 above.

Inactive ingredients

water, 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, cetyl PEG/PPG-10/1 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, propylparaben, isobutylparaben, fragrance.

Questions or comments?

Within US 1-800-950-4695

Dist. by: Guthy-Renker® LLC PO Box 14383
Palm Desert CA 92255-4383

PRINCIPAL DISPLAY PANEL - 75 mL Tube Box

Rodan & Fields
proactiv+

Clarifying
Night
Cream

2.5 FL. OZ. 75 mL

salicylic acid
acne treatment

PROACTIV PLUS CLARIFYING NIGHT 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-035
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-035-28	1 in 1 BOX	06/01/2015	12/02/2019
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	12/02/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020

Document Id: 2eda0aef-e413-4e47-889b-7590bf013d62

34390-5

Set id: 17d75607-2e67-4623-b321-9d5f76641bfa

Version: 2

Effective Time: 20200106

 

THE PROACTIV COMPANY LLC