SIGNATURE CARE COOL HEAT- menthol, methyl salicylate cream

Signature Care Cool Heat by

Drug Labeling and Warnings

Signature Care Cool Heat by is a Otc medication manufactured, distributed, or labeled by Safeway. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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?

1-888-723-3929

Principal Display Panel

Extra Strength

Cool Heat Cream

COLD & HOT Therapy For Pain

COMPARE TO Icy Hot® Cream active ingredients

Temporary relief of:

Arthritis, back aches, body aches & sore muscles

Extra Strength

Cool Heat Cream

MENTHOL 10%, METHYL SALICYLATE 30%

Pain Relieving Cream

COLD & HOT Therapy For Pain

COMPARE TO Icy Hot® Cream active ingredients

Temporary relief of:

Arthritis, back aches, body aches & sore muscles

NET WT 3 OZ (85 g)

INGREDIENTS AND APPEARANCE

SIGNATURE CARE COOL HEAT 
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-339
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	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: 21130-339-85	1 in 1 CARTON	12/02/2015
1		35 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 21130-339-21	1 in 1 CARTON	12/03/2015
2		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	12/02/2015

Labeler - Safeway (009137209)