Family Wellness hot And Cold Pain Relief

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
Description

Menthol - 10% Methyl salicylate -30%

Purpose

Topical Analgesic Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Topical Analgesic

Description

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.

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%

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
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

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  (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

Raw Label Data

All Sections (JSON)

Additional Information

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