METHYL SALICYLATE 25% CREAM- methyl salicylate 25% cream

Methyl Salicylate 25% Cream by

Drug Labeling and Warnings

Methyl Salicylate 25% Cream by is a Otc medication manufactured, distributed, or labeled by Forreal Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Methyl Salicylate 25% Cream
Forreal Pharmaceuticals, LLC

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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

Aloe vera leaf, Glycerine, Arnica Montana Flower, Indian Frankincense, Cetostearyl Alcohol, Ethylhexylglycerin, Glucosamine Sulfate, Glyceryl Monostearate, C13-14 Isoparaffin, Isosteryl Palmitate, Trolamine, Stearic Acid, Propylene Glycol, Laureth-7, Peg-100 Stearate, Water, Phenoxyethanol

Methyl Salicylate 25% Cream

NDC: 81877-721-01

120 grams

Manufactured for:
Forreal Pharmaceuticals, LLC
Royal Oak, MI 48067

PRINCIPAL DISPLAY PANEL

NDC: 81877-721-01
Methyl Salicylate 25% Cream
120 grams

Manufactured For:

Forreal Pharmaceuticals, LLC
Royal Oak, MI 48067
Questions or Comments Please call
877-367-3250

INGREDIENTS AND APPEARANCE

METHYL SALICYLATE 25% CREAM 
methyl salicylate 25% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81877-721
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81877-721-01	120 g in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	part348	04/15/2024

Labeler - Forreal Pharmaceuticals LLC (118029197)