YES TO TOMATOES ACNE CONTROL GEL CLEANSER- salicylic acid gel 
Autumn Harp, Inc.

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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Yes To Tomatoes Acne Control Gel Cleanser

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. 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 

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YES TO TOMATOES ACNE CONTROL GEL CLEANSER 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0329
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0329-1155 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/27/2011
Labeler - Autumn Harp, Inc. (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp, Inc.064187883manufacture(51514-0329)

Revised: 1/2014
Document Id: b2166f8a-0db3-4a61-8827-41d7ea4cac41
Set id: 2834672f-a2a0-4bda-85a9-3092a21b1be3
Version: 1
Effective Time: 20140106
 
Autumn Harp, Inc.