SPL v2
SPL
SPL Set ID 08f7c158-29c2-4d56-9f70-b6e40a2d3efe
Route
TOPICAL
Published
Effective Date 2010-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.25 g)
Inactive Ingredients
Aloe Vera Leaf Cetyl Alcohol Cinnamon Oil Eucalyptus Oil Glyceryl Monostearate Hypromellose Peppermint Oil Potassium Sorbate Water Squalane Stearic Acid Stearyl Alcohol Glycerin Grape Seed Oil Jojoba Oil Tea Tree Oil Methyl Salicylate Cetyl Esters Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-05-30
Description

Menthol 1.25%

Purpose

Pain relieving cream

Medication Information

Purpose
Pain relieving cream

Description

Menthol 1.25%

Use
Temporarily relieves minor aches and pains of muscles

and joints associated with:

simple backache

arthritis

strains

bruises

sprains
Section 51945-4
Image of the principal display panel




Warnings

For external use only

Directions
  • Adult and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a physician.
Do Not Use
on wounds or damaged skin
Active Ingredient

Menthol 1.25%

Inactive Ingredients
aloe vera gel, cetyl alcohol, cetyl esters, cinnamon oil, eucalyptus oil, glyceryl stearate, grape seed oil, hypromellose, jojoba oil, peppermint oil, potassium sorbate, purified water, squalane, stearic acid, stearyl alcohol, tea tree oil, vegetable glycerin, wintergreen oil.

When Using This Product
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
Stop Use and Ask A Doctor If
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Keep Out of Reach of Children


Structured Label Content

Use
Temporarily relieves minor aches and pains of muscles

and joints associated with:

simple backache

arthritis

strains

bruises

sprains
Section 51945-4 (51945-4)
Image of the principal display panel




Purpose
Pain relieving cream

Warnings

For external use only

Directions
  • Adult and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a physician.
Do Not Use (Do not use)
on wounds or damaged skin
Active Ingredient

Menthol 1.25%

Inactive Ingredients
aloe vera gel, cetyl alcohol, cetyl esters, cinnamon oil, eucalyptus oil, glyceryl stearate, grape seed oil, hypromellose, jojoba oil, peppermint oil, potassium sorbate, purified water, squalane, stearic acid, stearyl alcohol, tea tree oil, vegetable glycerin, wintergreen oil.

When Using This Product (When using this product)
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Keep Out of Reach of Children (Keep out of reach of children)


Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:06.451838 · Updated: 2026-03-14T22:52:26.166879