SMART SENSE COLD AND HOT EXTRA STRENGTH MEDICATED- menthol patch

Smart Sense Cold and Hot Extra Strength Medicated by

Drug Labeling and Warnings

Smart Sense Cold and Hot Extra Strength Medicated by is a Otc medication manufactured, distributed, or labeled by Kmart Corporation. 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

PREGNANCY OR BREAST FEEDING

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

WHEN USING

When using this product

• use only as directed
• do not bandage tightly or use with a 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
• symptoms persist for more than 7 days or clear up and occur again within a few days
• redness is present
• skin irritation develops
  

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

INDICATIONS & USAGE

Directions

• adults and children 12 years of age and 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 aloe vera, aluminum hydroxide, BHT, caster oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monostearate, polysorbate 80, polyvinyl alcohol, polyvinyl pyrrlidone, purified water, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate. Release Liner: polypropylene, non-woven material: polyester non-woven fabric.

DOSAGE & ADMINISTRATION

Distributed By: Kmart Corporation

Hoffman Estates, IL 60179

Made in South Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SMART SENSE COLD AND HOT EXTRA STRENGTH MEDICATED 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-296
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)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49738-296-25	1 in 1 CARTON
1		5 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 - Kmart Corporation (008965873)