FDA Label for Goodsense Extra Strength Cold And Hot Medicated

View Indications, Usage & Precautions

Goodsense Extra Strength Cold And Hot Medicated Product Label

The following document was submitted to the FDA by the labeler of this product Geiss, Destin And Dunn, 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
  • 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:
  • carefully remove backing from patch
  • apply sticky side of patch to affected area
  • should be used up to 8 hours
  • should be used no more than 3 times a day
  • children 12 years or younger: ask a doctor

Storage And Handling



Other information

  • Store at room temperature, not to exceed 86°F (30°C)
  • Reports of serious side effects associated with the use of this product can be sent to:
  • 17211 Valley View Ave. Cerritos, CA 90703

Inactive Ingredient



Inactive ingredients: Aloe Vera, Aluminum Hydroxide, Disodium Edate, Gelatin, Kaolin, Methylparaben, Glycerin, Titanium dioxide, Isopropyl Myristate, Purified Water, Polyvinyl Pyrrolidone, Polyvinyl Alcohol, Polysorbate 80, Tocopherol Acetate, Magnesium Aluminometasilicate, Castor Oil, Tartaric Acid, Polyethylene Glycol Monostearate, BHT, Sodium POlyacrylate. Release liner: Polypropylene, Non-woven material: Polyester non-woven fabric


Dosage & Administration



Distributed by: Geiss, Destin and Dunn, Inc.

Peachtree City, GA 30269

Made in Korea


Package Label.Principal Display Panel




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