drug facts

drug facts
SPL v1
SPL
SPL Set ID b771424d-2482-4b59-9cca-0752d64235f5
Route
topical
Published
Effective Date 2012-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (400 mg)
Inactive Ingredients
dihydroxyaluminum aminoacetate butylene glycol carboxymethylcellulose sodium glycerin diethylene glycol monoethyl ether edetate disodium methylparaben polysorbate 80 propylparaben water tartaric acid titanium dioxide

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2012-08-01
Purpose

Topical analgesic

Description

Menthol 5%

Medication Information

Warnings

For external use only

Uses
Temporarily relieves minor pain associated with:

  • arthritis
  • muscle strains
  • simple backache
  • bursitis
  • cramps
  • tendonitis
  • muscle sprains
  • bruises

Purpose
Topical analgesic

Directions

Adults and children over 12 years:

  • Remove backing from patch by grasping both ends firmly
  • Carefully remove backing from patch
  • Apply one patch to affected area
  • Repeat as necessary, but no more than 4 times daily

Children under 12 years of age: Ask a doctor

Other Information
store at room temperature

Inactive Ingredients

aluminium glycinate, 1,3-butylene glycol, carboxymethylcellulose sodium, concentrated glycerin, diethylene glycol monoethyl ether, disodium edetate, methyl parahydroxybenzoate, polyacrylic acid solution, polysorbate 80, propyl parahydroxybenzoate, purified water, tartaric acid, titanium dioxide

Description

Menthol 5%

Package Label



Cold and Hot Pain Relief Patch

Active Ingredient
Menthol 5%

When Using This Product
  • use only as directed
  • do not bandage tightly
  • do not use a heating pad
  • avoid contact with eyes and mucous membrane
  • do not apply to wounds or damaged skin
  • do not use if you are allergic to any ingredients of this product

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

If Pregnant Or Breast Feeding,
ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Warnings

For external use only

Uses
Temporarily relieves minor pain associated with:

  • arthritis
  • muscle strains
  • simple backache
  • bursitis
  • cramps
  • tendonitis
  • muscle sprains
  • bruises

Purpose
Topical analgesic

Directions

Adults and children over 12 years:

  • Remove backing from patch by grasping both ends firmly
  • Carefully remove backing from patch
  • Apply one patch to affected area
  • Repeat as necessary, but no more than 4 times daily

Children under 12 years of age: Ask a doctor

Other Information (Other information)
store at room temperature

Inactive Ingredients (Inactive ingredients)

aluminium glycinate, 1,3-butylene glycol, carboxymethylcellulose sodium, concentrated glycerin, diethylene glycol monoethyl ether, disodium edetate, methyl parahydroxybenzoate, polyacrylic acid solution, polysorbate 80, propyl parahydroxybenzoate, purified water, tartaric acid, titanium dioxide

Package Label (package label)



Cold and Hot Pain Relief Patch

Active Ingredient
Menthol 5%

When Using This Product (When using this product)
  • use only as directed
  • do not bandage tightly
  • do not use a heating pad
  • avoid contact with eyes and mucous membrane
  • do not apply to wounds or damaged skin
  • do not use if you are allergic to any ingredients of this product

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)
ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:30.471840 · Updated: 2026-03-14T22:53:14.066899