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NDC 00363-0017-26 Salicylic acid 5.05 mg/mL Details

Salicylic acid 5.05 mg/mL

Salicylic acid is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by WALGREEN COMPANY. 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: 00363-0017-26
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical

Product Information

NDC	00363-0017
Product ID	0363-0017_a6cf6163-4220-422e-b1e1-1433b5da9f19
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	Salicylic acid
Proprietary Name Suffix	n/a
Non-Proprietary Name	Salicylic acid
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	5.05
Active Ingredient Units	mg/mL
Substance Name	SALICYLIC ACID
Labeler Name	WALGREEN COMPANY
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 00363-0017-26 (00363001726)

Pricing Information	N/A
NDC Package Code	0363-0017-26
Billing NDC	00363001726
Package	1 BOTTLE, PUMP in 1 CARTON (0363-0017-26) / 118 mL in 1 BOTTLE, PUMP
Marketing Start Date	2015-12-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7462125c-6f19-44a3-b9be-37fff43a1a2f Details

Active ingredient

Salicylic acid 0.5%

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

clean the skin thoroughly before applying this product
cover the entire affected area with a thin layer one to three times daily
because excessive dryng of the skin may occur, start with one application daily, then gradualy increast to two or three times daily if needed or as directed by a doctor
if bothersome dryness or peeling occurs, reduce application to nce a day or every other day

Inactive ingredients

arachidyl alcohol, arachidyl glucoside, behenyl alcohol, BHT, bis-phenylpropyl dimethicone, C12-15 alkyl benzoate, C13-14 isoparaffin, cetearyl alcohol, cetearyl glucoside, dimethicone, disodium EDTA, ethylene/acrylic acid copolymer, fragrance, glycerin, Glycine soja (soybean) seed extract, isoceteth-20, laureth-7, methyl gluceth-20, polyacrylamide, PPG-10 cetyl ether, sodium hydroxide, water

SPL UNCLASSIFIED SECTION

Distributed by Walgreen Co.

200 Wilmot Road, Deerfield, IL 60015

100% satisifaction guaranteed

walgreens.com

principal display panel

Studio 35 Beauty

Daily Clarifying Face Daily Moisturizer

Salicylic Acid Acne Treatment

Helps prevent and treat breakouts

Oil-free

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

SALICYLIC ACID

salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0017
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5.05 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
DOCOSANOL (UNII: 9G1OE216XY)
BIS-PHENYLPROPYL DIMETHICONE (15 CST) (UNII: 4836494CFT)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
dimethicone (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN (UNII: L7HT8F1ZOD)
ISOCETETH-20 (UNII: O020065R7Z)
laureth-7 (UNII: Z95S6G8201)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
PPG-10 CETYL ETHER (UNII: Q056X4917J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0017-26	1 in 1 CARTON	12/19/2015
1		118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	12/19/2015

Labeler - WALGREEN COMPANY (008965063)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(0363-0017)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(0363-0017)

Revised: 9/2022

Document Id: a6cf6163-4220-422e-b1e1-1433b5da9f19

Set id: 7462125c-6f19-44a3-b9be-37fff43a1a2f

Version: 12

Effective Time: 20220923