family wellness hot and cold pain relief

SPL v3

SPL

SPL Set ID b70e343b-18aa-4e45-ae8e-79d8c84ad205

Route

topical

Published

Effective Date 2023-08-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

menthol (100 mg) salicylic acid (300 mg)

Inactive Ingredients

carbomer 940 edetate disodium anhydrous glyceryl stearate se polysorbate 80 potassium hydroxide stearic acid trolamine water

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2023-09-30

Purpose

Topical Analgesic Topical Analgesic

Description

Menthol - 10% Methyl salicylate -30%

Medication Information

Uses

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

simple backaches, arthritis, strains, bruises and sprains

Purpose

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.

Description

Menthol - 10% Methyl salicylate -30%

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.

Warning

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

Other Information

Store at controlled room temperature 20°- 25°C ( 68° to 77°F)

Active Ingredients

Menthol - 10%

Methyl salicylate -30%

Inactive Ingredients

Questions? 1 800 814 8028

When Using This Product

avoid contact with eyes and mucous membranes
do not bandage tightly

Principal Display Panel Tube

Family Wellness NDC 55319-824-35

Cold & Hot Pain Relief Cream

MENTHOL 10%

METHYL SALICYLATE 30%

NET WT 1.25 OZ (35.4g)

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 NDC 55319-824-35

Cold & Hot Pain Relief Cream

MENTHOL 10%

METHYL SALICYLATE 30%

NET WT 1.25 OZ (35.4g)

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

Purpose

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.

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.

Warning

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

Other Information (Other information )

Store at controlled room temperature 20°- 25°C ( 68° to 77°F)

Active Ingredients (Active ingredients )

Menthol - 10%

Methyl salicylate -30%

Inactive Ingredients (Inactive ingredients )

Questions? 1 800 814 8028 (Questions? 1-800 814-8028)

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 NDC 55319-824-35

Cold & Hot Pain Relief Cream

MENTHOL 10%

METHYL SALICYLATE 30%

NET WT 1.25 OZ (35.4g)

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 NDC 55319-824-35

Cold & Hot Pain Relief Cream

MENTHOL 10%

METHYL SALICYLATE 30%

NET WT 1.25 OZ (35.4g)

Advanced Ingredient Data

[{"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": "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", "Warning": "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", "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.", "Other information ": "Store at controlled room temperature 20°- 25°C ( 68° to 77°F)", "Active ingredients ": "Menthol - 10% Methyl salicylate -30%", "When using this product ": "avoid contact with eyes and mucous membranes do not bandage tightly", "Principal Display Panel -Tube": "Family Wellness NDC 55319-824-35 Cold & Hot Pain Relief Cream MENTHOL 10% METHYL SALICYLATE 30% NET WT 1.25 OZ (35.4g)", "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 NDC 55319-824-35 Cold & Hot Pain Relief Cream MENTHOL 10% METHYL SALICYLATE 30% NET WT 1.25 OZ (35.4g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:30.053549 · Updated: 2026-03-14T23:05:17.700396