SALICYLIC GEL- salicylic acid gel 
Malin and Goetz Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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salicylic gel

Active Ingredient Purpose

Salicylic Acid 2%--------Acne Treatment

Uses

For external use only

Keep out of reach of children.

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

Warnings:

For external use only.

When using this product

Avoid contact with eyes. If contact occurs, immediately flush with water.

Directions

Inactive ingredients

Water/Aqua/Eau, Alcohol Denat., Glycerin, Lactic Acid, Hydroxyethylcellulose, Sodium Hydroxide, Centella Asiatica Extract, Niacinamide, Phenoxyethanol, Salix Alba (Willow) Bark Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Disodium EDTA, Xanthan Gum, Mentha Piperita (Peppermint) Oil, Artemisia Absinthum Oil, Mentha Viridis (Spearmint) Leaf Oil, Tagetes Minuta Flower Oil, Achillea Millefolium Flower Extract.

Other Information

Protect the product in this container from excessive heat and direct sun.

Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor.

(MALIN+GOETZ)

salicylic gel.

2% Salicylic Acid. Acne Gel

Daytime Treatment

0.5fl.oz./15ml

Salicylic Gel carton

salicylic gel tube

SALICYLIC GEL 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53634-153
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SALIX ALBA BARK (UNII: 205MXS71H7)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
TAGETES MINUTA FLOWER OIL (UNII: 1T0ZMU8M8B)  
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
LACTIC ACID (UNII: 33X04XA5AT)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
NIACINAMIDE (UNII: 25X51I8RD4)  
WORMWOOD OIL (UNII: 01756N87N8)  
SPEARMINT OIL (UNII: C3M81465G5)  
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53634-153-0115 mL in 1 TUBE; Type 0: Not a Combination Product11/23/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00611/23/2022
Labeler - Malin and Goetz Inc (138615930)

Revised: 11/2022
Document Id: ee2acdf0-e5dd-9691-e053-2995a90ab49e
Set id: ee2acdf0-e5dc-9691-e053-2995a90ab49e
Version: 1
Effective Time: 20221123
 
Malin and Goetz Inc