FDA Label for Cvs Cold And Hot Medicated Xl

View Indications, Usage & Precautions

Cvs Cold And Hot Medicated Xl 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.

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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