BODY WASH- salicylic acid gel

Body Wash by

Drug Labeling and Warnings

Body Wash by is a Otc medication manufactured, distributed, or labeled by TopCo Associates LLC, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic acid (2.0%)

Purpose

Acne medication

Use

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 ame 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• for daily use in shower or bath.  Massage over wet skin with a washcloth or body pouf, concentrating on areas prone to breakouts.  Rinse well.

Inactive ingredients

water, sodium C14-16 olefin sulfonate, glycerin, cocamidopropyl betaine, acrylates copolymer, cocamidopropyl PG-dimonium chloride phosphate, polyquaternium-7, Citrus grandis (grapefruit) fruit extract, Anthemis nobilis flower extract, Camellia sinensis leaf extract, carrageenan, agar, neopentyl glycol dicaprylate/dicaprate, ascorbyl palmitate, propylene glycol, C12-15 alkyl lactate, polysorbate 20, butylene glycol, polyvinyl alcohol, disodium EDTA, sodium chloride, sodium hydroxide, benzalkonium chloride, sodium benzotriazolyl butylphenol sulfonate, fragrance, mica, titanium dioxide, iron oxides, red 30, red 40, ext. violet 2

SPL UNCLASSIFIED SECTION

Distributed by Topco Associates LLC, Elk Grove Village, IL 60007

1-888-423-0139 (c)Topco VIJ715 topcare@topco.comwww.topcarebrand.com

*This product is not manufactured or distributed by the Neutrogena Corporation, distributor of Body Clear Body Wash Pink Graperfuit

Principal Display Panel

Top Care

clarifying body wash pink grapefruit

Salicylic acid acne medication

foaming body wash

helps fight body breakouts

with grapefruit extract

dermatologist tested

*compare to Neutrogena

8.5 FL OZ (251 mL)

353.000/353AA-AC

INGREDIENTS AND APPEARANCE

BODY WASH 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-354
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
PUMMELO (UNII: ET1TN5W71X)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARRAGEENAN (UNII: 5C69YCD2YJ)
AGAR (UNII: 89T13OHQ2B)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYVINYL ALCOHOL (UNII: 532B59J990)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C RED NO. 40 (UNII: WZB9127XOA)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-354-23	251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/15/2015

Labeler - TopCo Associates LLC (006935977)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		790752542	manufacture(36800-354)