73557-192

73557-192
SPL v1
SPL
SPL Set ID 3ed34e65-9d74-daff-e063-6394a90a94c7
Route
TOPICAL
Published
Effective Date 2025-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.05 g)
Inactive Ingredients
Kaolin Tartaric Acid Water Dihydroxyaluminum Aminoacetate Anhydrous Propylene Glycol Polyacrylic Acid (250000 Mw) Carboxymethylcellulose Sodium Sodium Polyacrylate (2500000 Mw) Titanium Dioxide Mineral Oil Petrolatum Benzalkonium Chloride Lauralkonium Chloride Polysorbate 80 Glycerin Povidone K90 Lavender Oil Edetate Disodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-15

Description

Menthol 5% ...... Purpose: Topical analgesic

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 5% ...... Purpose: Topical analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthrits
  • strains
  • bruises
  • sprains
Stop Use

Stop use and ask a doctor if:

• you experience pain, swelling or blistering of the skin

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

• arthritic pain persists for more than 10 days, or redness is present

Warnings

For external use only

Ask Doctor

Stop use and ask a doctor if:

• you experience pain, swelling or blistering of the skin

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

• arthritic pain persists for more than 10 days, or redness is present

If pregnant or breastfeeding,ask a health professional before use.

Directions

• adults and children 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed gel-patch to site of pain. Carefully remove remaining film while pressing the gel-patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 3 to 4 times daily.

children under 12 years of age: consult a physician

• wash hands after use with cool water

Do Not Use

• do not apply to wounds or damaged skin

• do not apply to irritated skin or if excessive irritation develops

• do not bandage tightly or use with heating pad or device

When Using

When using this prudocts:

• use only as directed

• avoid contact with eyes or on mucous membranes

• do not apply to wounds or damaged skin

• do not apply to irritated skin or if excessive irritation develops

• do not bandage tightly or use with heating pad or device

Active Ingredient

Menthol 5% ...... Purpose: Topical analgesic

Other Information

• store at 68-77℉ (20-25℃)

• store in a cool dry place away from direct sunlight

Inactive Ingredients

Benzalkonium Chloride,Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin,Kaolin,Lauralkonium Chloride,Lavender Oil, Mineral Oil,Petrolatum, Polyacrylic Acid,Polysorbate 80, Propylene Glycol, Povidone K90,Sodium Polyacrylate,Tartaric Acid,Titanium Dioxide,Water

Questions Or Comments
Pregnancy Or Breast Feeding

If pregnant or breastfeeding,ask a health professional before use.

Keep Out of Reach of Children

If accidentally ingested, get medical help or contact a Poison Control Center immediately

Package Label. Principal Display Panel


Structured Label Content

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthrits
  • strains
  • bruises
  • sprains
Purpose

Topical analgesic

Stop Use (Stop use)

Stop use and ask a doctor if:

• you experience pain, swelling or blistering of the skin

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

• arthritic pain persists for more than 10 days, or redness is present

Warnings

For external use only

Ask Doctor (Ask doctor)

Stop use and ask a doctor if:

• you experience pain, swelling or blistering of the skin

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

• arthritic pain persists for more than 10 days, or redness is present

If pregnant or breastfeeding,ask a health professional before use.

Directions

• adults and children 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed gel-patch to site of pain. Carefully remove remaining film while pressing the gel-patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 3 to 4 times daily.

children under 12 years of age: consult a physician

• wash hands after use with cool water

Do Not Use (Do not use)

• do not apply to wounds or damaged skin

• do not apply to irritated skin or if excessive irritation develops

• do not bandage tightly or use with heating pad or device

When Using (When using)

When using this prudocts:

• use only as directed

• avoid contact with eyes or on mucous membranes

• do not apply to wounds or damaged skin

• do not apply to irritated skin or if excessive irritation develops

• do not bandage tightly or use with heating pad or device

Active Ingredient (Active ingredient)

Menthol 5% ...... Purpose: Topical analgesic

Other Information (Other information)

• store at 68-77℉ (20-25℃)

• store in a cool dry place away from direct sunlight

Inactive Ingredients (Inactive ingredients)

Benzalkonium Chloride,Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin,Kaolin,Lauralkonium Chloride,Lavender Oil, Mineral Oil,Petrolatum, Polyacrylic Acid,Polysorbate 80, Propylene Glycol, Povidone K90,Sodium Polyacrylate,Tartaric Acid,Titanium Dioxide,Water

Questions Or Comments (Questions or comments)
Pregnancy Or Breast Feeding (Pregnancy or breast feeding)

If pregnant or breastfeeding,ask a health professional before use.

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

If accidentally ingested, get medical help or contact a Poison Control Center immediately

Package Label. Principal Display Panel (Package label. Principal display panel)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)