Cvs Cold And Hot Medicated Xl
FDA Label NDC 59779-981

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 And Hot Medicated Xl (NDC 59779-981). 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
  • skin 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:

  • 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:

    consult a doctor

Storage And Handling

Other information

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

Inactive Ingredient

Inactive ingredients

aloe barbadensis leaf juice, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kanolin, magnesium aluminate metasilicate, methylparaben, peg-40 stearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate

release liner: polyethylene, non-woven material: polyester non-woven fabric.

Dosage & Administration

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

www.cvs.com               1-800-shop-CVS

Made in Korea

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