METHYL SALICYLATE 40 PERCENT- methyl salicylate cream

Methyl Salicylate 40 Percent by

Drug Labeling and Warnings

Methyl Salicylate 40 Percent by is a Otc medication manufactured, distributed, or labeled by Alexso, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Methyl Salicylate 40% Cream
Alexso, Inc

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Methyl Salicylate 40% Cream 

​Drug Facts

Active ingredient

Methyl Salicylate 40%

Purpose

Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, 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 of age: consult 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

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, 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, Polysorbate-20, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine

Methyl Salicylate 40% Cream

NDC: 50488-6040-6

60 gram

Manufactured for:
Alexso, Inc
2317 Cotner Ave
Los Angeles, CA 90064

PRINCIPAL DISPLAY PANEL

NDC: 50488-6040-6
Methyl Salicylate 40% Cream
Net Wt. 2 oz. 60 g

Rev 10/23

INGREDIENTS AND APPEARANCE

METHYL SALICYLATE 40 PERCENT 
methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50488-6040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	400 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
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)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50488-6040-6	60 g in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/01/2023

Labeler - Alexso, Inc (963338061)