Family Wellness Hot And Cold Pain Relief Cream
FDA Label NDC 55319-824

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar (family Wellness) for the product Family Wellness Hot And Cold Pain Relief (NDC 55319-824). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warning, when using this product, stop use and ask a doctor if;, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol - 10%

Methyl salicylate -30%

Purpose

Topical Analgesic

Topical Analgesic

Uses

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

  • simple backaches, arthritis, strains, bruises and sprains

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

When Using This Product

  • avoid contact with eyes and 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 occur

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)

Inactive Ingredients

Questions? 1-800 814-8028

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)

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)

Fd_coldhotpainrelief_carton (5504494 Fd Coldhotpainrelief Carton)

Fd_coldhotpainrelief_carton (5504494 Fd Coldhotpainrelief Carton)

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