Family Wellness Cold And Hot Pain Relief
FDA Label NDC 55319-026

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 for the product Family Wellness Cold And Hot Pain Relief (NDC 55319-026). 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 otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                               Purpose

Menthol 5% .....................................................................Topical analgesic

Otc - Purpose

Uses temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • bruises
  • cramps

Warnings

Warnings

For external use only

Otc - When Using

When using this product:

  • use only as directed
  • do not bandage tightly or use with heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

Otc - Stop Use

Stop use and ask a doctor if:

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  Do not use on infants.  If swallowed, get medical help or contact a Poison Control Center immediately

Indications & Usage

Directions

adults and children over 12 years:

  • carefully remove backing from patch
  • apply sticky side of patch to affected area
    • repeat as necessary, but no more than 4 times daily
      • children 12 years of younger:
      • ask a doctor

Inactive Ingredient

Inactive ingredients: Aloe Barbadensis Leaf Juice, Aluminum Hydroxide, Disodium EDTA, Gelatin, Kaolin, Methylparaben, Glycerin, Titanium Dioxide, Isopropyl Myristate, Purified Water,

Polyvinyl Pyrrolidone, Peg-4 Stearate, Polyvinyl Alcohol, Polysorbate 80, PVP, Tocopherol Acetate, Alumino Magnesium Metasilicate, Castor Oil, Tartaric Acid, BHT, Sodium Polyacrylate.

Dosage & Administration

DISTRIBUTED BY:

FAMILY DOLLAR SERVICES, INC.

10401 MONROE RD.,

MATTHEWS, NC 28105 USA

MADE IN KOREA

Package Label.Principal Display Panel

Image Of Carton Label (Fwcoldhotpatch)

Image Of Carton Label (Fwcoldhotpatch)

* Please review the disclaimer below.