GOODSENSE EXTRA STRENGTH COLD AND HOT MEDICATED- menthol patch

Goodsense Extra Strength Cold and Hot Medicated by

Drug Labeling and Warnings

Goodsense Extra Strength Cold and Hot Medicated by is a Otc medication manufactured, distributed, or labeled by Geiss, Destin and Dunn, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                                Purpose

Menthol 5%..........................................................Topical analgesic

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

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
  

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
  

PREGNANCY OR BREAST FEEDING

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOODSENSE EXTRA STRENGTH COLD AND HOT MEDICATED 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75981-124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	750 mg

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
GELATIN (UNII: 2G86QN327L)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
WATER (UNII: 059QF0KO0R)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CASTOR OIL (UNII: D5340Y2I9G)
TARTARIC ACID (UNII: W4888I119H)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75981-124-05	5 in 1 CARTON
1		1 in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/30/2013

Labeler - Geiss, Destin and Dunn, Inc. (076059836)