Cvs Cold Hot Medicated
FDA Label NDC 59779-821

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy Inc. for the product Cvs Cold Hot Medicated (NDC 59779-821). 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 drug facts, 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

Drug Facts

Active Ingredient                                                    Purpose

Menthol 5% .......................................................Topical Analgesic

Otc - Purpose

Uses

Temporarily relieves minor pain associated with:

  • Arthritis
  • Simple Backache
  • Bursitis
  • Tendonitis
  • Muscle Strains
  • Bruises
  • Cramps

Warnings

For external use only

Otc - When Using

When using this product

  • Use only as directed
  • Do not bandage tightly or use with a 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
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Redness is present
  • Skin irritation develops

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. If swallowed, get medical help or contact a Poision Control Center right away.

Indications & Usage

Directions: adults and children 12 years of age and older

  • Peel off protective backing and apply sticky side to affected area
  • Carefully remove backing from patch
  • Should be used up to 8 hours
  • Should be used no more than 3 times a day
  • Children under 12 years of age consult a doctor

Storage And Handling

Other Information

  • Store at room temperature, not to exceed 86° (30°C)

Inactive Ingredient

Inactive Ingredients:

1,3 butylene glycol, aloe vera (powder), dibutylhydroxytoluene, disodium edetate, d-sorbital solution, glycerine, kaolin, light liquid paraffin, magnesium aluminum hydrate, methacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium methaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, tocopherol acetate

Dosage & Administration

DISTRIBUTED BY:

CVS PHARMACY, INC.

ONE CVS DRIVE

WOONSOCKET, RI 02895 USA

* Please review the disclaimer below.