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, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine

Methyl Salicylate 25% Cream

NDC: 50488-1015-5

50 grams

Methyl Salicylate 25% Cream

NDC: 50488-1015-1

120 grams

Manufactured for:
Alexso, Inc
Los Angeles, CA 90064

PRINCIPAL DISPLAY PANEL

NDC 50488-1015-1
Methyl Salicylate 25% Cream
120 grams

PRINCIPAL DISPLAY PANEL
NDC 50488-1015-1
Methyl Salicylate 25% Cream
120 grams

Principal Display Panel

NDC 50488-1015-5
Methyl Salicylate 25% Cream
50 grams

METHYL SALICYLATE
methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50488-1015
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 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)
LAURETH-7 (UNII: Z95S6G8201)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50488-1015-1	120 g in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2019
2	NDC:50488-1015-5	50 g in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/01/2019

Labeler - Alexso, Inc (963338061)

Methyl Salicylate Cream