Cool & Heat Pain Relieving Liquid

Cool & Heat Pain Relieving Liquid
SPL v2
SPL
SPL Set ID ec6f59d8-45c5-46a0-e053-2995a90a239f
Route
TOPICAL
Published
Effective Date 2022-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (16 mg)
Inactive Ingredients
Carbomer Interpolymer Type B (allyl Pentaerythritol Crosslinked) Propylene Glycol Trolamine Alcohol Capsaicin Isopropyl Myristate Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-01

Description

Menthol 16%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 16%

Uses

Temporarily relieves minor muscle and joint pain associated with

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises.
Carton

*compare to the active ingredient

in Icy Hot®

a+health™

maximum strength

cool & heat

pain relieving liquid

menthol 16%

topical analgesic

rool-on applicator

  • no mess
  • dries rapidly
  • stain-free

2.5 fl oz (74mL)

Section 42229-5

Flammable

  • Keep away from fire or flame
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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
Section 50567-7

For external use only.

When using this product:

use only as directed

do not bandage tightly or use with a heating pad

avoid contact with eyes and mucous membranes

do not apply to wounds or damaged, broken or irritated skin

A temporary burning sensation may occur after use but normally disappears in several days.

If severe burning sensation occurs, discontinue use immediately

If swelling or blistering of the skin occurs, stop use and seek medical attention

Do not expose treated area to heat or direct sunlight.

Section 53414-9

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

Warnings

Directions

Adults and children over 12 yrs of age: apply to the affected area no more than 3 to 4 times daily

  • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

Children 12 years or younger: ask a doctor

Active Ingredient

Menthol 16%

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate, Propylene Glycol, Purified Water, SD Alcohol 40 (30%), Triethanolamine

Questions & Comments?

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)


Structured Label Content

Uses

Temporarily relieves minor muscle and joint pain associated with

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises.
Carton

*compare to the active ingredient

in Icy Hot®

a+health™

maximum strength

cool & heat

pain relieving liquid

menthol 16%

topical analgesic

rool-on applicator

  • no mess
  • dries rapidly
  • stain-free

2.5 fl oz (74mL)

Section 42229-5 (42229-5)

Flammable

  • Keep away from fire or flame
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

For external use only.

When using this product:

use only as directed

do not bandage tightly or use with a heating pad

avoid contact with eyes and mucous membranes

do not apply to wounds or damaged, broken or irritated skin

A temporary burning sensation may occur after use but normally disappears in several days.

If severe burning sensation occurs, discontinue use immediately

If swelling or blistering of the skin occurs, stop use and seek medical attention

Do not expose treated area to heat or direct sunlight.

Section 53414-9 (53414-9)

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

Purpose

Topical analgesic

Warnings

Directions

Adults and children over 12 yrs of age: apply to the affected area no more than 3 to 4 times daily

  • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

Children 12 years or younger: ask a doctor

Active Ingredient (Active ingredient)

Menthol 16%

Inactive Ingredients (Inactive ingredients)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate, Propylene Glycol, Purified Water, SD Alcohol 40 (30%), Triethanolamine

Questions & Comments? (Questions & comments?)

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)