COOL AND HEAT- menthol liquid

Cool and Heat by

Drug Labeling and Warnings

Cool and Heat by is a Otc medication manufactured, distributed, or labeled by AMERISOURCE BERGEN, Bionpharma Inc., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 16%

Purpose

Topical analgesic

Uses

temporarily relieves minor muscle and joint pain associated with ▪ arthritis ▪ simple backache ▪ muscle strains ▪ sprains ▪ bruises

Warnings

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 a severe burning sensation occurs, discontinue use immediately ▪ If swelling or blistering of the skin occurs, stop use and seek and seek medical attention ▪ Do not expose treated area to hear or direct sunlight.

Stop use and ask a doctor

▪ condition worsens ▪ redness is present ▪ irritation develops ▪ symptoms persist for more than 7 days or clear up and occur again within a few days

SPL UNCLASSIFIED SECTION

Flammable ▪ Keep away from fire or flame

KEEP OUT OF REACH OF CHILDREN

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

PREGNANCY OR BREAST FEEDING

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

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

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)

Carton label

NDC: 46122-743-27

GOOD

NEIGHBOR
PHARMACY®

Maximum Strength

Cool & Heat

Menthol 16%

Topical Analgesic

Pain Relieving Liquid

Roll-on Applicator

No Mess
Dries Rapidly
Stain-free

2.5 fl oz (74mL)

actual size

package contains one bottle

*This product is not

manufactured or distributed

by Chattem Inc., owner of

the registered trademark

Icy Hot®.

Distributed By

AmerisourceBergen
1 West First Ave
Conshohocken, PA 19428
Questions or Concerns?
www.mygnp.com
ABC#: 10274880

L0000658

R1022

INGREDIENTS AND APPEARANCE

COOL AND HEAT 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-743
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
ALCOHOL (UNII: 3K9958V90M)
CAPSAICIN (UNII: S07O44R1ZM)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46122-743-27	1 in 1 CARTON	03/15/2023
1		74 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/15/2023

Labeler - AMERISOURCE BERGEN (007914906)

Registrant - Bionpharma Inc. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	label(46122-743) , pack(46122-743) , analysis(46122-743) , manufacture(46122-743)