drug facts

drug facts
SPL v1
SPL
SPL Set ID 75bc6993-cd63-4eba-bdb9-5c5370cc951c
Route
topical
Published
Effective Date 2011-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (400 mg)
Inactive Ingredients
acrylic acid aluminum hydroxide carboxymethylcellulose sodium glycerin isopropyl myristate methyl acrylate nonoxynol-30 polysorbate 80 water sorbitan sesquioleate talc tartaric acid titanium dioxide

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2011-09-12
Purpose

Topical analgesic

Description

Menthol 5%

Medication Information

Warnings

For external use only

Uses
Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • bruises
  • cramps
Purpose
Topical analgesic

Directions
Adults and children over 12 years:

  • carefully remove backing from patch

  • apply sticky side of patch to affected area

  • repeat as necessary, but no more than 4 times daily
Inactive Ingredients

2-ethylhexyl acrylate, acrylic acid, aluminium hydroxide, carboxymethylcellulose sodium, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylic acid, polysorbate 80, purified water, sodium polyacrylate, sorbitan sesquioleate, starch, talc, tartaric acid, titanium oxide

Description

Menthol 5%

Package Label


Best Choice Cold and Hot Small Medicated Patch
Active Ingredient
Menthol 5%

When Using This Product
  • use only as directed
  • do not bandage tightly or use with heating pad

  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin
Stop Use and Ask A Doctor If
  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast Feeding,
ask a health professional before use.

Keep Out of Reach of Children.

For use on children 12 years or younger consult a doctor. Do not use on infants. If swallowed, get medical help or contact a Poison Control Center immediately.

Structured Label Content

Warnings

For external use only

Uses
Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • bruises
  • cramps
Purpose
Topical analgesic

Directions
Adults and children over 12 years:

  • carefully remove backing from patch

  • apply sticky side of patch to affected area

  • repeat as necessary, but no more than 4 times daily
Inactive Ingredients (Inactive ingredients)

2-ethylhexyl acrylate, acrylic acid, aluminium hydroxide, carboxymethylcellulose sodium, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylic acid, polysorbate 80, purified water, sodium polyacrylate, sorbitan sesquioleate, starch, talc, tartaric acid, titanium oxide

Package Label (package label)


Best Choice Cold and Hot Small Medicated Patch
Active Ingredient
Menthol 5%

When Using This Product (When using this product)
  • use only as directed
  • do not bandage tightly or use with heating pad

  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
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.)

For use on children 12 years or younger consult a doctor. Do not use on infants. If swallowed, get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:21.087216 · Updated: 2026-03-14T22:52:53.430326