Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 454bbde9-3076-6977-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2017-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.025 g)
Inactive Ingredients
Allantoin Aloe Vera Leaf Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Dmdm Hydantoin Glycerin Methylparaben Phenoxyethanol Propylparaben Alcohol Steareth-2 Steareth-21 Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2008-06-01
Description

Active Ingredient Menthol 2.5%

Purpose

Topical Analgesic

Medication Information

Warnings and Precautions

For external use only

Purpose

Topical Analgesic

Description

Active Ingredient Menthol 2.5%

Uses

Temporarily relives minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • muscle sprains
  • bruises
  • cramps

Section 50565-1

If swallowed, get medical help or contact a poison control center immediately.

Section 51727-6

Allantoin, Aloe Barbadensis Leaf Juice, Carbomer, DMDM Hydantoin, Glycerin, Methylparaben, Phenoxyethanol, Propylparaben, SD Alcohol 40 (15.47%), Steareth-2, steareth-21, Triethanolamine, water.

Section 51945-4

Section 55106-9

Active Ingredient

Menthol 2.5%

Directions

Adults and children over 2 years:

  • wash hand thoroughly with soap and water after use
  • apply generously to affected area
  • squeeze desired amount of gel onto affected area
  • using the sponge-top applicator, massage dispensed gel into painful area until thoroughly absorbed
  • repeat as necessary, but no more than 4 times daily

Children 2 years or younger:

  • Ask a doctor

Questions Or Comments

1-800-635-3696

When Using This Product
  • Use only as directed
  • wash hand thoroughly with soap and water after use
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged skin

Stop Use and Ask Doctor If
  • Condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

If Pregnant Or Breast Feeding

ask a health care professional before use.

Structured Label Content

Uses

Temporarily relives minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • muscle sprains
  • bruises
  • cramps

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a poison control center immediately.

Section 51727-6 (51727-6)

Allantoin, Aloe Barbadensis Leaf Juice, Carbomer, DMDM Hydantoin, Glycerin, Methylparaben, Phenoxyethanol, Propylparaben, SD Alcohol 40 (15.47%), Steareth-2, steareth-21, Triethanolamine, water.

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active Ingredient

Menthol 2.5%

Purpose

Topical Analgesic

Directions

Adults and children over 2 years:

  • wash hand thoroughly with soap and water after use
  • apply generously to affected area
  • squeeze desired amount of gel onto affected area
  • using the sponge-top applicator, massage dispensed gel into painful area until thoroughly absorbed
  • repeat as necessary, but no more than 4 times daily

Children 2 years or younger:

  • Ask a doctor

Questions Or Comments (Questions or comments)

1-800-635-3696

When Using This Product (When using this product)
  • Use only as directed
  • wash hand thoroughly with soap and water after use
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged skin

Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • Condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health care professional before use.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:14.374743 · Updated: 2026-03-14T22:54:35.350687