METHYL SALICYLATE 25% CREAM- methyl salicylate cream 
Medcore LLC

----------

Methyl Salicylate 25% Cream

​

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 olderapply externally to the affected area up to 3 to 4 times a day
children under 2 yearsask 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

Label-1

PRINCIPAL DISPLAY PANEL

NDC: 82461-415-05

Medcore LLC

Methyl Salicylate 25% Cream

50mL

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

Label-2

METHYL SALICYLATE 25% CREAM 
methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82461-415
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE250 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82461-415-10120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/14/2025
2NDC:82461-415-0550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/14/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/14/2025
Labeler - Medcore LLC (069802634)

Revised: 7/2025
Document Id: 2dddf0c3-d666-41b7-9155-64034f7bf54f
Set id: 143f76bf-2de4-466a-8a6b-d6ab6314a2c3
Version: 2
Effective Time: 20250714
 
Medcore LLC