Menthol 5% (topical Analgesic)

Menthol 5% (topical Analgesic)
SPL v17
SPL
SPL Set ID 189c313d-f0a3-4593-852e-addbe9082524
Route
TOPICAL
Published
Effective Date 2013-09-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (50 mg)
Inactive Ingredients
Silodrate Butylated Hydroxytoluene Castor Oil Carboxymethylcellulose Sodium Edetate Disodium Gelatin Glycerin Isopropyl Myristate Kaolin Methylparaben Peg-4 Stearate Polysorbate 80 Polyvinyl Alcohol Water Tartaric Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-08-15
Description

Active Ingredient Menthol 5%

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

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

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises
Dosage and Administration

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 no more than 3 to 4 times daily
  • children under 12 years of age consult a doctor
  • For best results, please ensure that the skin is clean and dry before applying
  • reseal pouch
Description

Active Ingredient Menthol 5%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop using this product if

  • condition worsens
  • excessive skin irritation occurs
  • redness is present
  • symptoms persist more than 7 days or clear up and occur again within a few days
If pregnant or breastfeeding consult a healthcare professional before use
Section 50567-7

When using this product

  • avoid contact with eyes and mucous membranes
  • do not bandage tightly
  • do not use with a heating pad or other heating device
Section 50569-3

Ask a doctor before use if you

  • have redness over the affected area
  • are pregnant or breastfeeding
Section 50570-1

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions
Section 51727-6

Inactive Ingredients BHT, castor oil, cellulose gum, disodium edetate, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, PEG-4 stearate, polyacrylic acid, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate, tartaric acid, titanium dioxide. Release Liner: polyethylene, Non-Woven Material: polyester non-woven fabric.

Section 51945-4


Section 53413-1

Questions? Call toll-free 1-800-645-3867

Section 55105-1

Purpose

Topical Analgesic

Section 55106-9

Active Ingredient

Menthol 5%

Structured Label Content

Indications and Usage (34067-9)

Uses

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

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises
Dosage and Administration (34068-7)

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 no more than 3 to 4 times daily
  • children under 12 years of age consult a doctor
  • For best results, please ensure that the skin is clean and dry before applying
  • reseal pouch
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop using this product if

  • condition worsens
  • excessive skin irritation occurs
  • redness is present
  • symptoms persist more than 7 days or clear up and occur again within a few days
If pregnant or breastfeeding consult a healthcare professional before use
Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes and mucous membranes
  • do not bandage tightly
  • do not use with a heating pad or other heating device
Section 50569-3 (50569-3)

Ask a doctor before use if you

  • have redness over the affected area
  • are pregnant or breastfeeding
Section 50570-1 (50570-1)

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions
Section 51727-6 (51727-6)

Inactive Ingredients BHT, castor oil, cellulose gum, disodium edetate, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, PEG-4 stearate, polyacrylic acid, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate, tartaric acid, titanium dioxide. Release Liner: polyethylene, Non-Woven Material: polyester non-woven fabric.

Section 51945-4 (51945-4)


Section 53413-1 (53413-1)

Questions? Call toll-free 1-800-645-3867

Section 55105-1 (55105-1)

Purpose

Topical Analgesic

Section 55106-9 (55106-9)

Active Ingredient

Menthol 5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:42.062403 · Updated: 2026-03-14T22:53:35.925326