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Cool Heat

Safeway

Safeway Inc. Cool Heat Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Menthol 10%

Methyl salicylate 30%

Purpose

Topical analgesic

Cool Heat 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

Cool Heat 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-SAFEWAY

Principal Display Panel

Extra Strength

Compare to Icy Hot® Cream active ingredients

Cool Heat

Pain Relieving Cream

Cold & Hot Therapy for Pain

NET WT 3 OZ (85 g)

Cool Heat

Menthol, Methyl salicylate CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:21130-692
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 10 g
methyl salicylate METHYL SALICYLATE 30 g

Inactive Ingredients

Ingredient Name Strength
CETYL ESTERS WAX
OLETH-3 PHOSPHATE
water
STEARIC ACID
TROLAMINE

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 85 in 1 TUBE
2 NDC:21130-692-60 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2013-10-15


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Be sure to consult your doctor before taking any medication!
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