FDA Label for Meijer Extra Strength Cold And Hot Medicated

View Indications, Usage & Precautions

Meijer Extra Strength Cold And Hot Medicated Product Label

The following document was submitted to the FDA by the labeler of this product Meijer. 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 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 - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Otc - Pregnancy Or Breast Feeding



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


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°F (30°C)

Inactive Ingredient



Inactive ingredients aloe vera, aluminum hydroxide, BHT, caster oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monostearate, polysorbate 80, polyvinyl alcohol, polyvinyl pyrrolidone, purified water, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate. Release Liner: polypropylene, non-woven material: polyester non-woven fabric.


Dosage & Administration



Distributed By:

Meijer Distribution, Inc.

2929 Walker Ave

Grand Rapids, MI 49544


Package Label.Principal Display Panel




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