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

Description

Drug Facts

Purpose

Topical Analgesic


Medication Information

Purpose
  • Topical Analgesic
Description

Drug Facts

Uses

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

■arthritis ■backache ■strains■sprains

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.

Warnings

For external use only

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
Active Ingredient

Menthol 2%

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

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

Uses

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

■arthritis ■backache ■strains■sprains

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.

Purpose
  • Topical Analgesic
Warnings

For external use only

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
Active Ingredient

Menthol 2%

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

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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