METHYL SALICYLATE 25% CREAM- methyl salicylate cream

Methyl Salicylate 25% Cream by

Drug Labeling and Warnings

Methyl Salicylate 25% Cream by is a Otc medication manufactured, distributed, or labeled by Medcore LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Methyl Salicylate 25%

Purpose

Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.

Warnings

​For external use only.

When using this product

• - Avoid contact with the eyes
• - Do not use in larger quantities, particularly over raw surfaces or blistered areas
• - Do not apply to wounds or damaged skin
• - Do not bandage

Stop use and ask a doctor if

• - allergic reaction occurs
• - condition worsens or does not improve within 7 days
• - symptoms clear up and return within a few days
• - redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of the reach of children.

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

Directions

• adults and children 2 years and older: apply externally to the affected area up to 3 to 4 times a day
• children under 2 years: ask a doctor

Other Information

• - May be applied under occlusive dressing.
• - Store at 20-25-C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

Inactive Ingredients

Glycerine, CETOSTEARYLALCOHOL, ETHYLHEXYLGLYCERIN, GLUCOSAMINE SULFATE, CHONDROITIN SULFATE, (BOVINE), GLYCERYL MONOSTEARATE, C13-14ISOPARAFFIN, ISOSTEARYL PALMITATE, TROLAMINE, STEARIC ACID, PROPYLENE GLYCOL, LAURETH-7, PEG-100 STEARATE, Water, PHENOXYETHANOL.

Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

PRINCIPAL DISPLAY PANEL

NDC: 82461-415-10

Medcore LLC

Methyl Salicylate 25% Cream

120mL

Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

INGREDIENTS AND APPEARANCE

METHYL SALICYLATE 25% CREAM 
methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82461-415
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	250 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	60 mg  in 1 mL
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	10 mg  in 1 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	20 mg  in 1 mL
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)	10 mg  in 1 mL
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)	5 mg  in 1 mL
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)	10 mg  in 1 mL
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)	10 mg  in 1 mL
ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)	30 mg  in 1 mL
TROLAMINE (UNII: 9O3K93S3TK)	20 mg  in 1 mL
STEARIC ACID (UNII: 4ELV7Z65AP)	30 mg  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	50 mg  in 1 mL
LAURETH-7 (UNII: Z95S6G8201)	30 mg  in 1 mL
PEG-100 MONOSTEARATE (UNII: YD01N1999R)	50 mg  in 1 mL
WATER (UNII: 059QF0KO0R)	410 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	5 mg  in 1 mL

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82461-415-10	120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/14/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/14/2025

Labeler - Medcore LLC (069802634)