REVIVE ACNE REPARATIF ACNE TREATMENT GEL- salicylic acid cream

ReVive Acne Reparatif Acne by

Drug Labeling and Warnings

ReVive Acne Reparatif Acne by is a Otc medication manufactured, distributed, or labeled by RéVive Skincare. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Salicylic Acid 0.5%

Purpose

Acne Medication

Use

For the treatment of acne

Warnings

For external use only.

When using this product

• apply to affected areas only
• using other topical acne medication at the same time may increase dryness or irritation of the skin. If irritation occurs, use only one medication at a time.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• clean the skin thoroughly before applying
• cover the entire affected area with a thin layer 1 to 3 times daily. Avoid eye area.
• as excess drying of the skin may occur, begin with 1 application daily then increase to 2 or 3 times daily, if needed, or as directed by a physician
• if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Other information

Protect container from heat and flame. Do not smoke when applying this product. Keep container tightly closed.

Inactive ingredients

Water, Alcohol Denat., Cyclopentasiloxane, PVM/MA Decadiene Crosspolymer, Dimethicone, Oligopeptide-10, sh-Oligopeptide-1, Phenoxyethanol, PPG-26-Buteth-26, Sodium Hydroxide, Butylene Glycol, Panthenol, PEG-40 Hydrogenated Castor Oil, Polysilicone-11, Saccharomyces Lysate Extract, Glycerin, Caprylyl Glycol, Chlorphenesin, Decyl Glucoside, Avena Sativa (Oat) Kernel Extract, Hexylene Glycol, Potassium Sorbate, Citrus Aurantium Dulcis (Orange) Peel Oil, Citric Acid, Pantolactone, Limonene.

Questions or comments?

Call 1-866-986-7083, M – F 8am – 5pm CST.

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

ACNE
REPARATIF

RéVive

Acne
Treatment Gel

Salicylic Acid 0.5%

30 ml/1 fl. oz. liq. US

INGREDIENTS AND APPEARANCE

REVIVE ACNE REPARATIF ACNE  TREATMENT GEL
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-414
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
OLIGOPEPTIDE-10 (UNII: Q46328TRNK)
NEPIDERMIN (UNII: TZK30RF92W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PANTHENOL (UNII: WV9CM0O67Z)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
OAT (UNII: Z6J799EAJK)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ORANGE OIL (UNII: AKN3KSD11B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PANTOLACTONE, (R)- (UNII: J288D7O0JS)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-414-60	1 in 1 CARTON	09/01/2008
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	09/01/2008

Labeler - RéVive Skincare (193691821)