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cool heat

Kroger Company

Kroger Co. Cool Heat Pain Relieving Cream 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
  • •redness is present
  • •irritation develops
  • •symptoms persist for more than 7 days or clear up and occur again within a few days

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?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredients of ICY HOT®

See bottom panel

EXTRA STRENGTH

Cool Heat

PAIN RELIEVING CREAM

Cold and Hot Therapy for Pain

Arthritis

Backache

Sore Muscles

Body Aches

NET WT 1.25 OZ (35 g)

cool heat

Menthol, Methyl salicylate CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-692
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
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
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 35 in 1 TUBE
2 NDC:30142-692-85 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2010-05-21


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