Family Wellness Ultra Strength Muscle Rub Cream

SPL v3

SPL

SPL Set ID 554c7d3c-09f4-4923-b4ca-d5de8f7e2c9a

Route

TOPICAL

Published

Effective Date 2023-08-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Camphor (synthetic) (40 mg) Menthol (100 mg) Salicylic Acid (300 mg)

Inactive Ingredients

Carbomer 940 Edetate Disodium Anhydrous Glyceryl Stearate Se Lanolin Polysorbate 80 Potassium Hydroxide Stearic Acid Trolamine Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-09-30

Description

Camphor- 4% Menthol - 10% Methyl salicylate -30%

Purpose

Topical Analgesic Topical Analgesic Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Camphor- 4% Menthol - 10% Methyl salicylate -30%

Uses

For temporary relief of minor aches and pains of muscle and joints associated with;

simple backaches, arthritis, strains, bruises and sprains

Section 50565-1

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Drug Facts

Directions

Use only as directed

Adults and children 2 years of age and older;

Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age; ask a doctor.

Warnings

For external use only

Do not use

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

Ask a doctor before use if you have; redness over thre affected area

Active Ingredients

Camphor- 4%

Menthol - 10%

Methyl salicylate -30%

Other Information

Store at controlled room temperature 20°- 25°C ( 68° to 77°F)
Close cap tightly afteruse.

Inactive Ingredients

Carbomer, Disodium ETDA, Glyceryl Sterate SE, Lanolin, Polysorbate 80, Potassium Hydroxide, Stearic Acid, Triethanolamine, Water (purified)

When Using This Product

avoid contact with eyes and mucous membranes
do not bandage tightly

Principal Display Panel Tube

Family Wellness 55319-820-57

Ultra Strength

Pain Relief Cream

Camphor 4%, Menthol 10%, Methyl Salicylate 30%

NET WT 2.0 OZ (57g)

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 occur

Principal Display Panel Carton

Family Wellness 55319-820-57

Ultra Strength

Pain Relief Cream

Camphor 4%, Menthol 10%, Methyl Salicylate 30%

NET WT 2.0 OZ (57g)

Structured Label Content

Uses

For temporary relief of minor aches and pains of muscle and joints associated with;

simple backaches, arthritis, strains, bruises and sprains

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Purpose

Topical Analgesic

Drug Facts (DRUG FACTS)

Directions

Use only as directed

Adults and children 2 years of age and older;

Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age; ask a doctor.

Warnings

For external use only

Do not use

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

Ask a doctor before use if you have; redness over thre affected area

Active Ingredients

Camphor- 4%

Menthol - 10%

Methyl salicylate -30%

Other Information (Other information )

Store at controlled room temperature 20°- 25°C ( 68° to 77°F)
Close cap tightly afteruse.

Inactive Ingredients (Inactive ingredients )

Carbomer, Disodium ETDA, Glyceryl Sterate SE, Lanolin, Polysorbate 80, Potassium Hydroxide, Stearic Acid, Triethanolamine, Water (purified)

When Using This Product (When using this product )

avoid contact with eyes and mucous membranes
do not bandage tightly

Principal Display Panel Tube (Principal Display Panel -Tube)

Family Wellness 55319-820-57

Ultra Strength

Pain Relief Cream

Camphor 4%, Menthol 10%, Methyl Salicylate 30%

NET WT 2.0 OZ (57g)

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 occur

Principal Display Panel Carton (Principal Display Panel - Carton )

Family Wellness 55319-820-57

Ultra Strength

Pain Relief Cream

Camphor 4%, Menthol 10%, Methyl Salicylate 30%

NET WT 2.0 OZ (57g)

Advanced Ingredient Data

[{"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "ACTIB", "strengthNumerator": "40", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "300", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CARBOMER 940", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM ANHYDROUS", "unii": "8NLQ36F6MM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL STEARATE SE", "unii": "FCZ5MH785I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM HYDROXIDE", "unii": "WZH3C48M4T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For temporary relief of minor aches and pains of muscle and joints associated with; simple backaches, arthritis, strains, bruises and sprains", "50565-1": "Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.", "Purpose": "Topical Analgesic Topical Analgesic Topical Analgesic", "Directions": "Use only as directed Adults and children 2 years of age and older; Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age; ask a doctor.", "Warnings ": "For external use only Do not use on wounds or damaged skin with a heating pad on a child under 12 years of age with arthritis-like condiitions Ask a doctor before use if you have; redness over thre affected area", "Active Ingredients": "Camphor- 4% Menthol - 10% Methyl salicylate -30%", "Other information ": "Store at controlled room temperature 20°- 25°C ( 68° to 77°F) Close cap tightly afteruse.", "Inactive ingredients ": "Carbomer, Disodium ETDA, Glyceryl Sterate SE, Lanolin, Polysorbate 80, Potassium Hydroxide, Stearic Acid, Triethanolamine, Water (purified)", "When using this product ": "avoid contact with eyes and mucous membranes do not bandage tightly", "Principal Display Panel -Tube": "Family Wellness 55319-820-57 Ultra Strength Pain Relief Cream Camphor 4%, Menthol 10%, Methyl Salicylate 30% NET WT 2.0 OZ (57g)", "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 occur", "Principal Display Panel - Carton ": "Family Wellness 55319-820-57 Ultra Strength Pain Relief Cream Camphor 4%, Menthol 10%, Methyl Salicylate 30% NET WT 2.0 OZ (57g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:29.236236 · Updated: 2026-03-14T23:05:15.511736