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 large 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 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

Aqua (Deionized Water), Arnica Montana Flower Extract, Indian Frankincense, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Monostearate, Cetostearyl Alcohol, Aloe Vera Leaf, C13-14 Isoparaffin, Isostearyl Palmitate, Trolamine, Laureth-7, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Stearic Acid.

Methyl Salicylate 25% Pump Bottle Cream

NDC: 50488-1016-5

50 mL

Manufactured for:
Alexso, Inc
Los Angeles, CA 90064

Tel: 888.495.6078

PRINCIPAL DISPLAY PANEL

NDC 50488-1016-5
Methyl Salicylate 25% Pump Bottle Cream
50 mL

Rev 05/24

NDC 50488-1016-5
Methyl Salicylate 25% Pump Bottle Cream
50 mL
Rev 05/24

METHYL SALICYLATE 25 PERCENT
methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50488-1016
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)
TROLAMINE (UNII: 9O3K93S3TK)
LAURETH-7 (UNII: Z95S6G8201)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50488-1016-5	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	05/01/2024

Labeler - Alexso, Inc (963338061)

Methyl Salicylate 25_Percent Pump Cream