YES TO TOMATOES ACNE CONTROL GEL CLEANSER- salicylic acid gel

YES TO TOMATOES ACNE CONTROL GEL CLEANSER by

Drug Labeling and Warnings

YES TO TOMATOES ACNE CONTROL GEL CLEANSER by is a Otc medication manufactured, distributed, or labeled by Autumn Harp, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

Drug Facts

Active Ingredients

Salicylic Acid 1%

Purpose

Acne Treatment

Uses:

for the treatment of acne

Warnings:

For external use only · When using this product Skin irritation and dryness is 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 the eyes. If contact occurs, flush thoroughly with water.

KEEP OUT OF REACH OF CHILDREN

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

Directions:

Clean 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, Lauryl Glucoside, Cocamidopropyl Betaine, Propanediol, Glycerin, Sodium Chloride, Aloe Barbadensis Leaf Extract*, Solanum Lycopersicum (Tomato) Extract*, Phenethyl Alcohol, Glyceryl Caprylate, Citric Acid, Alcohol, Fragrance. *Certified Organic Ingredient 

Principal Display Panel

Image Components

INGREDIENTS AND APPEARANCE

YES TO TOMATOES ACNE CONTROL GEL CLEANSER 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0329
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
glycerin (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENETHYL ALCOHOL (UNII: ML9LGA7468)
BENZYL BENZOATE (UNII: N863NB338G)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALCOHOL (UNII: 3K9958V90M)
TOMATO (UNII: Z4KHF2C175)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
COUMARIN (UNII: A4VZ22K1WT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0329-1	155 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/27/2011

Labeler - Autumn Harp, Inc. (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Inc.		064187883	manufacture(51514-0329)