Kmart Corporation Cool Heat Cream Drug Facts

smart sense cool heat by

Drug Labeling and Warnings

smart sense cool heat by is a Otc medication manufactured, distributed, or labeled by Kmart Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SMART SENSE COOL HEAT- menthol, methyl salicylate cream 
Kmart Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Kmart Corporation Cool Heat Cream Drug Facts

Active ingredients

Menthol 10%

Methyl salicylate 30%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with

• arthritis
• simple backache
• strains
• sprains
• bruises

Warnings

For external use only

When using this product

• use only as directed
• do not bandage tightly
• do not use with a heating pad
• avoid contact with the eyes or mucous membranes
• do not apply to wounds or damaged or irritated skin

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
• irritation develops

Keep out of reach of children.

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

Directions

adults and children over 12 years

• apply generously to affected area
• massage into painful area until thoroughly absorbed into skin
• repeat as necessary, not more than 3 to 4 times daily

children 12 years or younger ask a doctor

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

carbomer homopolymer, cetyl esters wax, emulsifying wax, oleth-3 phosphate, purified water, stearic acid, trolamine

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS IN ICY HOT® CREAM

COLD & HOT THERAPY FOR PAIN

PAIN RELIEVING CREAM

ARTHRITIS

BACK ACHES

BODY ACHES

SORE MUSCLES

COMPARE TO THE ACTIVE INGREDIENTS IN ICY HOT® CREAM

EXTRA STRENGTH

cool heat cream

PAIN RELIEVING CREAM

ARTHRITIS

BACK ACHES

BODY ACHES

SORE MUSCLES

NET WT 3 OZ (85 g)

SMART SENSE COOL HEAT 
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-692
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ESTERS WAX (UNII: D072FFP9GU)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49738-692-21	1 in 1 CARTON	07/24/2011	10/09/2018
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/24/2011	10/09/2018

Labeler - Kmart Corporation (008965873)

Revised: 12/2019

Document Id: 6db812cd-7ef3-4115-9c1d-f0f2d664662d

34390-5

Set id: 49f6448a-b15c-49f7-9bf9-7ea24c65e07e

Version: 4

Effective Time: 20191217