Better Living Brands LLC Cool Heat Cream Drug Facts

Manufacturer
Safeway
Effective date
2019-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:51:00

Label at a glance#

ProductSignature Care Cool Heat
Active ingredientMENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure9 sections

Indications and uses

temporarily relieves minor pain associated with • arthritis • simple backache • strains • sprains • bruises

Dosage and administration

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

Storage and handling

store at 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Methyl salicylate 30%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-888-723-3929

Principal Display Panel

PACKAGE LABEL.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)

Signature Care Cool Heat Cream image 1
Signature Care Cool Heat Cream image 1
Signature Care Cool Heat Cream image 2
Signature Care Cool Heat Cream image 2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-33921130-339-85, 21130-339-21

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
323ec093-8738-43a6-9d33-d3a857537b6e057d917a-d5fb-4c6f-bf85-181235a9e6dd2024-10-22WarningsExact identifier
spl set id: 057d917a-d5fb-4c6f-bf85-181235a9e6dd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.