ACNE WASH- salicylic acid liquid 
Harmon Stores 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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FACE VALUES OIL-FREE PINK GRAPEFRUIT FACIAL & BODY ACNE WASH

Active Ingredients

Salicylic Acid 2.0%

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 eyes. If contact occurs, flush thoroughly with water.

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

Directions

Other information

Inactive Ingredients

water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, sodium chloride, linoleamidopropyl PG-dimonium chloride phosphate, polysorbate 20, anthemis nobilis flower extract, citrus grandis (grapefruit) fruit extract, aloe barbadensis leaf juice, chamomilla recutita (matricaria) flower extract, C12-15 alkyl lactate, cocamidopropyl PG-dimononium chloride phosphate, polyquaternium-7, ascorbyl palmitate, propylene glycol, sodium benzotriazolyl butylphenol sulfonate, PEG-120 methyl glucose dioleate, PEG-80 sorbitan laurate, disodium EDTA, benzalkonium chloride, fragrance, red 40, Ext. Violet 2

FACE VALUES OIL-FREE PINK GRAPEFRUIT FACIAL & BODY ACNE WASH

9.1 FL OZ (269mL)

NDC 63940-053-54

Label9.1

FACE VALUES OIL-FREE PINK GRAPEFRUIT FACIAL & BODY ACNE WASH

2 FL OZ (59mL)

NDC 63940-053-61

Label2

ACNE WASH 
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-053
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
PUMMELO (UNII: ET1TN5W71X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHAMOMILE (UNII: FGL3685T2X)  
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
PEG-80 SORBITAN LAURATE (UNII: 239B50Y732)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63940-053-54269 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/05/2016
2NDC:63940-053-6159 mL in 1 BOTTLE; Type 0: Not a Combination Product02/05/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H02/05/2016
Labeler - Harmon Stores Inc. (804085293)
Registrant - Fruit of the Earth, Inc. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
Fruit of the Earth, Inc.008193513manufacture(63940-053)

Revised: 3/2020
Document Id: 91b68342-9e60-4a38-a1db-ab408fea2c8a
Set id: 9d0451a5-c8f9-4d0f-9928-fbc90ef134fe
Version: 1
Effective Time: 20200319
 
Harmon Stores Inc.