drug facts

drug facts
SPL v1
SPL
SPL Set ID 2df08319-cf75-493f-87bf-a525c8585528
Route
topical
Published
Effective Date 2011-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

Topical Analgesic Patch

Description

Menthol 5.0%

Medication Information

Warnings

For external use only

Uses
For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Purpose
Topical Analgesic Patch

Directions
  • Adults and children 10 years of age and older: Apply to affected area not more than 3 to 4 times daily
  • Children under 10 years of age: do not use, consult a doctor
Inactive Ingredients

Purified Water, Acrylic Acid, Aluminum Hydroxide, Carmellose sodium, 2-Ethylhexyl Acrylate, Glycerin, Isopropyl Myristate, Methyl Acrylate, Nonoxymol-30, Sodium Polyacrylate, Polyacrylic Acid, Polysorbate 80, Sorbitan Sesquioleate, Starch, Talc, Tartaric acid, Titanium Dioxide

Description

Menthol 5.0%

Package Label


QC Cold and Hot Patch
Active Ingredient
Menthol 5.0%

When Using This Product
  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop Use and Ask A Doctor If
condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
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
For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Purpose
Topical Analgesic Patch

Directions
  • Adults and children 10 years of age and older: Apply to affected area not more than 3 to 4 times daily
  • Children under 10 years of age: do not use, consult a doctor
Inactive Ingredients (Inactive ingredients)

Purified Water, Acrylic Acid, Aluminum Hydroxide, Carmellose sodium, 2-Ethylhexyl Acrylate, Glycerin, Isopropyl Myristate, Methyl Acrylate, Nonoxymol-30, Sodium Polyacrylate, Polyacrylic Acid, Polysorbate 80, Sorbitan Sesquioleate, Starch, Talc, Tartaric acid, Titanium Dioxide

Package Label (package label)


QC Cold and Hot Patch
Active Ingredient
Menthol 5.0%

When Using This Product (When using this product)
  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:21.082034 · Updated: 2026-03-14T22:52:53.430326