METHYL SALICYLATE- methyl salicylate cream 
Preferred Pharmaceuticals Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Methyl Salicylate Cream

Methyl Salicylate 25% Cream
Alexso, Inc

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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 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: 68788-7925-1

120 grams

Manufactured for:
Alexso, Inc
Los Angeles, CA 90064

PRINCIPAL DISPLAY PANEL

NDC 68788-7925-1
Methyl Salicylate 25% Cream
120 grams

Relabeled By: Preferred Pharmaceuticals Inc.

Methyl Salicylate 25% Cream
METHYL SALICYLATE 
methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7925(NDC:50488-1015)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE250 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-7925-1120 g in 1 BOTTLE; Type 0: Not a Combination Product08/13/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/13/2021
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7925)

Revised: 8/2023
Document Id: 4d86001b-82d6-4e65-a2ed-6bd2a87e557c
Set id: 854b9070-f810-44e2-968a-4230bb032662
Version: 3
Effective Time: 20230803
 
Preferred Pharmaceuticals Inc.