FDA Label for Cvs Cold Hot Medicated

View Indications, Usage & Precautions

Cvs Cold Hot Medicated Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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