Goodsense Extra Strength Cold And Hot Medicated Patch
FDA Label NDC 50804-126

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geiss, Destin And Dunn, Inc. for the product Goodsense Extra Strength Cold And Hot Medicated (NDC 50804-126). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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