Cool Heat

Cool Heat
SPL v1
SPL
SPL Set ID a91ddaa4-8426-4761-899f-faebe662be11
Route
TOPICAL
Published
Effective Date 2016-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 g) Salicylic Acid (30 g)
Inactive Ingredients
Carboxypolymethylene Cetyl Esters Wax Oleth-3 Phosphate Stearic Acid Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-06-29

Description

Active ingredients Menthol                 10% Methyl salicylate    30%


Medication Information

Warnings and Precautions

Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Indications and Usage

Uses

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps
Dosage and Administration

Directions

Adults and Children over 12 years:

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

Children 12 years or younger: ask a doctor

Description

Active ingredients Menthol                 10% Methyl salicylate    30%

Section 50565-1

Keep out of reach of children.

If case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Section 50566-9

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
Section 50567-7

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
Section 51727-6

Inactive ingredients

carbomer, cetyl esters, emulsifying wax, oleth-3 phosphate, stearic acid, triethanolamine, water.

Section 51945-4

PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH

COOL HEAT PAIN RELIEVING CREAM

NET WT 1.25 OZ (35 g)

Section 53414-9

If pregnant or breast-feeding, ask a health care professional before use.

Section 55105-1

Purpose

Topical analgesic

Section 55106-9

Active ingredients

Menthol                 10%

Methyl salicylate    30%


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps
Dosage and Administration (34068-7)

Directions

Adults and Children over 12 years:

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

Children 12 years or younger: ask a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Section 50565-1 (50565-1)

Keep out of reach of children.

If case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
Section 50567-7 (50567-7)

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
Section 51727-6 (51727-6)

Inactive ingredients

carbomer, cetyl esters, emulsifying wax, oleth-3 phosphate, stearic acid, triethanolamine, water.

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH

COOL HEAT PAIN RELIEVING CREAM

NET WT 1.25 OZ (35 g)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health care professional before use.

Section 55105-1 (55105-1)

Purpose

Topical analgesic

Section 55106-9 (55106-9)

Active ingredients

Menthol                 10%

Methyl salicylate    30%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)