ACNE WASH- salicylic acid liquid

ACNE WASH by

Drug Labeling and Warnings

ACNE WASH by is a Otc medication manufactured, distributed, or labeled by Harmon Stores Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Salicylic Acid 2.0%

Purpose

Acne Treatment

Uses

for the treatment of acne.

Warnings

For external use only

WHEN USING

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

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

Directions

• cover the entire affected area with a thin layer and rinse thoroughly 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

Other information

• may stain some fabrics

Inactive Ingredients

water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, chamomilla recutita (matricaria) flower extract, cocamidopropyl PG-dimonium chloride phosphate, propylene glycol, aloe barbadensis leaf juice, anthemis nobilis flower extract, C12-15 alkyl lactate, PEG-80 sorbitan laurate, disodium EDTA, benzalkonium chloride, fragrance, yellow 5, red 40.

PRINCIPAL DISPLAY PANEL

FACE VALUES OIL-FREE ACNE WASH

9.1 FL OZ (269mL)

NDC: 63940-052-54

FACE VALUES OIL-FREE ACNE WASH

2 FL OZ (59mL)

NDC: 63940-052-61

INGREDIENTS AND APPEARANCE

ACNE WASH 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-052
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
PEG-80 SORBITAN LAURATE (UNII: 239B50Y732)
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-052-54	269 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/26/2019
2	NDC: 63940-052-61	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/11/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	11/11/2015

Labeler - Harmon Stores Inc. (804085293)

Registrant - Fruit of the Earth, Inc. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit of the Earth, Inc.		008193513	manufacture(63940-052)