Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2ed99606-a2e7-4f92-8773-4239740bb433
Route
TOPICAL
Published
Effective Date 2011-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (428.5 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 2011-09-07
Description

Menthol 5%

Purpose

Topical analgesic

Medication Information

Purpose
Topical analgesic

Description

Menthol 5%

Uses
  • temporarily relieves minor aches and pains of muscles and joints associated with:
    • simple backache
    • arthritis
    • bruises
    • sprains

Warnings

For external use only

Directions
  • open pouch and remove patch
  • if desired, cut patch to size
  • peel off protective backing and apply sticky side to affected area
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a doctor

Do Not Use
  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Package Label


Pain Relieving Patch, 4pk



----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



Bulk Patch

Active Ingredient
Menthol 5%

Other Information

  • store at 20 ° to 25 ° C (68 ° F to 77 ° F)



Inactive Ingredients

Purified Water, Acrylic Acid, Aluminum Hydroxide, Carboxymethylcellulose 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

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
  • excessive skin irritation occurs

Keep Out of Reach of Children.

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

Ask A Doctor Before Using If You Have
  • redness over the affected area

Structured Label Content

Uses
  • temporarily relieves minor aches and pains of muscles and joints associated with:
    • simple backache
    • arthritis
    • bruises
    • sprains

Purpose
Topical analgesic

Warnings

For external use only

Directions
  • open pouch and remove patch
  • if desired, cut patch to size
  • peel off protective backing and apply sticky side to affected area
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a doctor

Do Not Use (Do not use)
  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Package Label (package label)


Pain Relieving Patch, 4pk



----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



Bulk Patch

Active Ingredient
Menthol 5%

Other Information (Other information)

  • store at 20 ° to 25 ° C (68 ° F to 77 ° F)



Inactive Ingredients (Inactive ingredients)

Purified Water, Acrylic Acid, Aluminum Hydroxide, Carboxymethylcellulose 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

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
  • excessive skin irritation occurs

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

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

Ask A Doctor Before Using If You Have (Ask a doctor before using if you have)
  • redness over the affected area

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:21.094276 · Updated: 2026-03-14T22:52:53.430326