Methyl Salicylate by ViolaCare, Inc. METHYL SALICYLATE cream

Methyl Salicylate by

Drug Labeling and Warnings

Methyl Salicylate by is a Otc medication manufactured, distributed, or labeled by ViolaCare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient                                               Purpose

Methyl Salicylate 25%........................................Topical Analgesic

PURPOSE

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:

• simple backache
• lumbago
• arthritis
• neuralgia
• strains
• bruises
• 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 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 reach of children.

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

DOSAGE & ADMINISTRATION

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° C-25° C (68° F-77° F); excursions permitted to 15° C-30° C (59° F-86° F). See USP Controlled Room Temperature.

Inactive Ingredients

C13-14 isoparaffin, cetearyl alcohol, chondrotin sulfate sodium, Ethylhexylglycerin, glucosamine sulfate potassium chloride, glycerin, glyceryl stearate, isostearic acid, laureth-7, PEG-100 stearate, phenoxyethanol, polyacrylamide, propylene glycol, stearic acid, water

QUESTIONS

Questions?Call 877-227-3137

PRINCIPAL DISPLAY PANEL

Methyl Salicylate 25% Cream - NDC: 85231-201-60 - Pain Relieving Cream - Topical Analgesic - 2.11 OZ (60g)

Carton Label

Methyl Salicylate 25% Cream - NDC: 85231-201-60 - Pain Relieving Cream - Topical Analgesic - 2.11 OZ (60g)

Box Label

Manufactured For:

ViolaCare, Inc.

Parsippany, New Jersey, 07054

INGREDIENTS AND APPEARANCE

METHYL SALICYLATE 
methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85231-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	25 g  in 60 g

Inactive Ingredients
Ingredient Name	Strength
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHONDROITIN SULFATE SODIUM, SHARK (UNII: Q75WVO004L)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOSTEARIC ACID (UNII: X33R8U0062)
LAURETH-7 (UNII: Z95S6G8201)
PEG-100 MONOSTEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85231-201-60	1 in 1 CARTON	06/02/2025
1		60 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/02/2025

Labeler - ViolaCare, Inc. (119452160)