drug facts

drug facts
SPL v1
SPL
SPL Set ID 1ff58c3a-95c1-4ca0-81d8-ce580f08481d
Route
topical
Published
Effective Date 2012-11-20
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 sorbitan sesquioleate talc tartaric acid titanium dioxide water

Identifiers & Packaging

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

Topical Analgesic

Description

Menthol 5.0%

Medication Information

Warnings

For external use only

Uses

temporarily relieves minor pain associated with

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

Topical Analgesic

Directions

Adults and children over 12 years:

  • carefully remove backing from patch
  • apply one patch to affected area
  • repeat as necessary, but no more than 4 times daily

Children 12 years or younger: ask a doctor

Inactive Ingredients

Acrylic Acid, Aluminum Hydroxide, Carmellose sodium, 2-Ethylhexyl Acrylate, Glycerin, Isopropyl Myristate, Methyl Acrylate, Nonoxymol-30, Sodium Polyacrylate, Polyacrylic Acid, Polysorbate 80, Purified Water, 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
  • use only as directed
  • avoid contact with eyes and mucous membranes
  • do not bandage tightly or use with a heating pad
  • do not apply to wounds or damaged skin, broken or irritated 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.

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

Topical Analgesic

Directions

Adults and children over 12 years:

  • carefully remove backing from patch
  • apply one patch to affected area
  • repeat as necessary, but no more than 4 times daily

Children 12 years or younger: ask a doctor

Inactive Ingredients (Inactive ingredients)

Acrylic Acid, Aluminum Hydroxide, Carmellose sodium, 2-Ethylhexyl Acrylate, Glycerin, Isopropyl Myristate, Methyl Acrylate, Nonoxymol-30, Sodium Polyacrylate, Polyacrylic Acid, Polysorbate 80, Purified Water, 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)
  • use only as directed
  • avoid contact with eyes and mucous membranes
  • do not bandage tightly or use with a heating pad
  • do not apply to wounds or damaged skin, broken or irritated 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.)

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: 2026-02-15T11:55:33.690831 · Updated: 2026-03-14T22:53:20.556394