healthwise pain relieving menthol gel

healthwise pain relieving menthol gel
SPL v1
SPL
SPL Set ID 396d0fd4-67be-4de1-8f0c-42c83dfe9120
Route
topical
Published
Effective Date 2025-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (2 g)
Inactive Ingredients
ammonia carbomer homopolymer type c (allyl pentaerythritol crosslinked) cupric sulfate fd&c blue no. 1 isopropyl alcohol magnesium sulfate anhydrous thymol water sodium hydroxide peg-40 hydrogenated castor oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-12-01

Purpose

Topical Analgesic

Description

Drug Facts


Medication Information

Warnings

For external use only

Uses

Uses Temporary relief from minor aches and pains of sore muscles and joints associated with:

■arthritis ■backache ■strains■sprains

Purpose
  • Topical Analgesic
Directions

Directions

  • clean affected area before applying product
  • Adults and children 2 years of age and older apply to the affected area not more than 3 to 4 times daily
  • Children under 2 years of age, ask a doctor before using this product
Other Information
  • do not freeze
  • store at room temperature
  • keep container tightly closed when  not in use
  • do not use, pour, spill or store near heat or open flame
Inactive Ingredients

ammonium hydroxide, carbopol 940, cupric sulfate, FD&C blue No. 1, Isopropyl alcohol, magnesium sulphate, PEG-40 hydrogenated castor oil sodium hydroxide, thymol, water

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, get medical help orcontact a Poison Control Center (800-222-1222) right away.

Section 51945-4

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Active Ingredient

Menthol 2%

Stop Use and Ask A Doctor If

Stop use and ask a doctor if: the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again withing a few days.

When Using This Product, Do Not

When using this product:

■ do not use with other topical pain relievers

■do not use with a heating pads or other heating devices

■ avoid contact with eyes 

■do not bandage tightly

■ do not apply to wounds or damaged skin


Structured Label Content

Warnings

For external use only

Uses

Uses Temporary relief from minor aches and pains of sore muscles and joints associated with:

■arthritis ■backache ■strains■sprains

Purpose
  • Topical Analgesic
Directions

Directions

  • clean affected area before applying product
  • Adults and children 2 years of age and older apply to the affected area not more than 3 to 4 times daily
  • Children under 2 years of age, ask a doctor before using this product
Other Information (Other information)
  • do not freeze
  • store at room temperature
  • keep container tightly closed when  not in use
  • do not use, pour, spill or store near heat or open flame
Inactive Ingredients (Inactive ingredients)

ammonium hydroxide, carbopol 940, cupric sulfate, FD&C blue No. 1, Isopropyl alcohol, magnesium sulphate, PEG-40 hydrogenated castor oil sodium hydroxide, thymol, water

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, get medical help orcontact a Poison Control Center (800-222-1222) right away.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Active Ingredient

Menthol 2%

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if: the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again withing a few days.

When Using This Product, Do Not (When using this product, do not)

When using this product:

■ do not use with other topical pain relievers

■do not use with a heating pads or other heating devices

■ avoid contact with eyes 

■do not bandage tightly

■ do not apply to wounds or damaged skin


Advanced Ingredient Data


Raw Label Data

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