Pain Reliever Gel

SPL v3

SPL

SPL Set ID 18536e21-afc3-8447-e063-6394a90aabae

Route

TOPICAL

Published

Effective Date 2021-01-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Menthol, Unspecified Form (25 mg)

Inactive Ingredients

Butylated Hydroxytoluene Camphor (synthetic) Carbomer Homopolymer, Unspecified Type Isoceteth-20 Isopropyl Alcohol Polyoxyl 40 Hydrogenated Castor Oil Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-01-24

Description

Drug Facts

Purpose

Topical analgesic

Medication Information

Purpose

Topical analgesic

Description

Drug Facts

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

simple backache
arthritis
strains
bruises
sprains

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50569-3

Ask a doctor before use if you haveredness over the affected area

Warnings

For external use only.

Directions

adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 12 years of age: ask a doctor

Do Not Use

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

Questions?

call 1-800-223-0182(toll-free) or 215-273-8755(collect)

Active Ingredient

Menthol 2.5%

Other Information

store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

camphor, carbomer, DMDM hydantoin, isoceteth-20, isopropyl alcohol, PEG-40 hydrogenated castor oil, sodium hydroxide, water

When Using This Product

avoid contact with eyes or mucous membranes
do not bandage tightly

Stop Use and Ask A Doctor If

condition worsens or symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
excessive skin irritation occurs

Principal Display Panel 57 G Tube Carton

Extra Strength Muscle Rub

Pain Reliever Gel

Fast Penetrating

MENTHOL 2.5% TOPICAL ANALGESIC GEL

NET WT 1 OZ (35.4 g)

Structured Label Content

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

simple backache
arthritis
strains
bruises
sprains

Section 42229-5 (42229-5)

Drug Facts

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 50569-3 (50569-3)

Ask a doctor before use if you haveredness over the affected area

Purpose

Topical analgesic

Warnings

For external use only.

Directions

adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 12 years of age: ask a doctor

Do Not Use (Do not use)

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

Questions?

call 1-800-223-0182(toll-free) or 215-273-8755(collect)

Active Ingredient (Active ingredient)

Menthol 2.5%

Other Information (Other information)

store at 20° to 25°C (68° to 77°F)

Inactive Ingredients (Inactive ingredients)

camphor, carbomer, DMDM hydantoin, isoceteth-20, isopropyl alcohol, PEG-40 hydrogenated castor oil, sodium hydroxide, water

When Using This Product (When using this product)

avoid contact with eyes or mucous membranes
do not bandage tightly

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

condition worsens or symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
excessive skin irritation occurs

Principal Display Panel 57 G Tube Carton (PRINCIPAL DISPLAY PANEL - 57 g Tube Carton)

Extra Strength Muscle Rub

Pain Reliever Gel

Fast Penetrating

MENTHOL 2.5% TOPICAL ANALGESIC GEL

NET WT 1 OZ (35.4 g)

Advanced Ingredient Data

[{"name": "BUTYLATED HYDROXYTOLUENE", "unii": "1P9D0Z171K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOCETETH-20", "unii": "O020065R7Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves the minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50569-3": "Ask a doctor before use if you have redness over the affected area", "Purpose": "Topical analgesic", "Warnings": "For external use only.", "Directions": "adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor", "Do not use": "on wounds or damaged skin with a heating pad on a child under 12 years of age with arthritis-like conditions", "Questions?": "call 1-800-223-0182 (toll-free) or 215-273-8755 (collect)", "Active ingredient": "Menthol 2.5%", "Other information": "store at 20° to 25°C (68° to 77°F)", "Inactive ingredients": "camphor, carbomer, DMDM hydantoin, isoceteth-20, isopropyl alcohol, PEG-40 hydrogenated castor oil, sodium hydroxide, water", "When using this product": "avoid contact with eyes or mucous membranes do not bandage tightly", "Stop use and ask a doctor if": "condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive skin irritation occurs", "PRINCIPAL DISPLAY PANEL - 57 g Tube Carton": "Extra Strength Muscle Rub Pain Reliever Gel Fast Penetrating MENTHOL 2.5% TOPICAL ANALGESIC GEL NET WT 1 OZ (35.4 g)"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:50.631661 · Updated: 2026-03-14T23:13:16.476899