SALICYLIC GEL- salicylic acid gel

salicylic gel by

Drug Labeling and Warnings

salicylic gel by is a Otc medication manufactured, distributed, or labeled by Malin and Goetz Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Purpose

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

PURPOSE

Uses

For external use only

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

WARNINGS

Warnings:

For external use only.

When using this product

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

DOSAGE & ADMINISTRATION

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 drying of the skin may occur, start with one application daily, then gradually increase totwo oe three times daily if needed or as directed by a doctor.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

INACTIVE INGREDIENT

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 SAFETY INFORMATION

Other Information

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

INDICATIONS & USAGE

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.

PRINCIPAL DISPLAY PANEL

(MALIN+GOETZ)

salicylic gel.

2% Salicylic Acid. Acne Gel

Daytime Treatment

0.5fl.oz./15ml

INGREDIENTS AND APPEARANCE

SALICYLIC GEL 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53634-153
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53634-153-01	15 mL in 1 TUBE; Type 0: Not a Combination Product	11/23/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	11/23/2022

Labeler - Malin and Goetz Inc (138615930)