1. Home
  2. Labeler Index
  3. Geiss, Destin And Dunn, Inc.
  4. 50804-126
  5. Label Information: Goodsense Extra Strength Cold And Hot Medicated

FDA Label for Goodsense Extra Strength Cold And Hot Medicated

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - WHEN USING
    5. OTC - STOP USE
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. INDICATIONS & USAGE
    8. STORAGE AND HANDLING
    9. INACTIVE INGREDIENT
    10. DOSAGE & ADMINISTRATION
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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

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
  • redness is present
  • skin irritations 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 immediately.


Indications & Usage



Directions

  • adults and children 12 years of age or 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

1,3-butylene glycol, aloe vera (powder), dibutylhydroxtoluene, disodium edetate, d-sorbitol solution, gelatin, glycerin, kaolin, light liquid paraffin, magnesium aluminium hydrate, metacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purifed water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium oxide, tocopherol acetate


Dosage & Administration



Distributed By:

Geiss, Destin and Dunn, Inc.

Peachtree City, Ga 30269

Made in Korea


* Please review the disclaimer below.