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NDC 36800-0947-30 Oil Free Acne Wash 20.6 mg/mL Details

Oil Free Acne Wash 20.6 mg/mL

Oil Free Acne Wash is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates, LLC. The primary component is SALICYLIC ACID.

MedlinePlus Drug Summary

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or birthmarks. Salicylic acid is in a class of medications called keratolytic agents. Topical salicylic acid treats acne by reducing swelling and redness and unplugging blocked skin pores to allow pimples to shrink. It treats other skin conditions by softening and loosening dry, scaly, or thickened skin so that it falls off or can be removed easily.

Related Packages: 36800-0947-30
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical

Product Information

NDC	36800-0947
Product ID	36800-947_b5f37356-41cc-4eb6-9b87-70a3a0888f1d
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	Oil Free Acne Wash
Proprietary Name Suffix	n/a
Non-Proprietary Name	Salicylic acid 2%
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	20.6
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 36800-0947-30 (36800094730)

Pricing Information	N/A
NDC Package Code	36800-947-30
Billing NDC	36800094730
Package	177 mL in 1 BOTTLE, PUMP (36800-947-30)
Marketing Start Date	2009-05-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3149260c-b92b-43a7-8f57-897517102fa8 Details

active ingredient

Salicylic Acid 2%

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 same time. If irritation occurs, only use one topical acne medication at a time

Keep out of reach of children

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

Directions

use up to twice a daily. Wet face, apply to hands, add water and work into lather. Massage face gently. Rinse well.
avoid contact with eyes. If contact occurs, flush thoroughly with water.

Inactive ingredients

water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, glycerin, sodium chloride, decyl glucoside, disodium EDTA, fragrance, linoleamidopropyl PG-dimonium chloride phosphate, propylene glycol, Aloe barbadensis leaf extract, Anthemis nobilis flower extract, Chamomilla recutita (matricaria) flower extract, yellow 5, red 40

disclaimer

This product is not manufactured or distributed by Neutrogena Corporation.

Adverse Reactions Section

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

1-888-423-0139 TOPCO VIJ117

[email protected] www.topcarebrand. com.

principal display panel

Top Care

beauty

OIL-FREE

ACNE WASH

Salicylic Acid

Acne treatment

Compare to

NEUTROGENA

Dermatologist tested

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

OIL FREE ACNE WASH

salicylic acid 2% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-947
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Salicylic acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Salicylic acid	20.6 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
CHAMOMILE (UNII: FGL3685T2X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-947-30	177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/21/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	05/21/2009

Labeler - Topco Associates, LLC (006935977)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(36800-947)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(36800-947)

Revised: 3/2022

Document Id: b5f37356-41cc-4eb6-9b87-70a3a0888f1d

Set id: 3149260c-b92b-43a7-8f57-897517102fa8

Version: 11

Effective Time: 20220321