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NDC 36800-0354-23 Body Wash 25 mg/mL Details

Body Wash 25 mg/mL

Body Wash is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by TopCo Associates LLC. The primary component is SALICYLIC ACID.

Product Information

NDC	36800-0354
Product ID	36800-354_24b03151-fabc-4dbc-81e4-cb9fc268d738
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Body Wash
Proprietary Name Suffix	n/a
Non-Proprietary Name	Salicylic Acid
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	25
Active Ingredient Units	mg/mL
Substance Name	SALICYLIC ACID
Labeler Name	TopCo Associates LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333D
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0354-23 (36800035423)

Pricing Information	N/A
NDC Package Code	36800-354-23
Billing NDC	36800035423
Package	251 mL in 1 BOTTLE, PLASTIC (36800-354-23)
Marketing Start Date	2015-01-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1b16b978-70e0-4bba-a8d7-a77d7e1f896a Details

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 [email protected]www.topcarebrand.com

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

Principal Display Panel

TopCare

beauty

CLARIFYING BODY WASH

Pink Grapefruit

Salicylic Acid

Acne Treatment

Compare to NEUTROGENA

Helps fight body breakouts

Dermatologist tested

with Grapefuit Extract

8.5 FL OZ (251 mL)

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - TopCo Associates LLC (006935977)

Registrant - Vi-Jon, LLC (790752542)

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

Revised: 3/2022

Document Id: 24b03151-fabc-4dbc-81e4-cb9fc268d738

Set id: 1b16b978-70e0-4bba-a8d7-a77d7e1f896a

Version: 10

Effective Time: 20220307