Active ingredient

Methyl Salicylate 25%

Purpose

External 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 larger 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 the 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 barbadensis leaf extract, cetyl alcohol, glyceryl stearate SE, mineral oil, PEG-100 stearate, peppermint oil, phenoxyethanol, propylene glycol, purified water, stearyl alcohol, white petrolatum, xanthan gum.

MANUFACTURED FOR:
Marcella Health

Cheyene, WY 82001
Questions or Comments
(307) 410-3813 or info@marcellahealth.com

PRINCIPAL DISPLAY PANEL

Drug Facts:

Methyl Salicylate Box

METHYL SALICYLATE 25% CREAM
methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:85096-001
Route of Administration	CUTANEOUS

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
XANTHAN GUM (UNII: TTV12P4NEE)
MINERAL OIL (UNII: T5L8T28FGP)
PEPPERMINT OIL (UNII: AV092KU4JH)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-100 STEARATE (UNII: YD01N1999R)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:85096-001-42	120 g in 1 TUBE; Type 0: Not a Combination Product	04/15/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	04/15/2025

Labeler - MARCELLA HEALTH (119381899)

Methyl Salicylate 25% Cream