Goodsense Extra Strength Cold And Hot Medicated
FDA Label NDC 75981-124

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 75981-124). 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 - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, 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

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

Image Of Carton Label (Gslgcoldhotpatch)

Image Of Carton Label (Gslgcoldhotpatch)

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