COOL AND HEAT- menthol liquid 
AMERISOURCE BERGEN

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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GNP Cool & Heat

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

Flammable ▪ Keep away from fire or flame

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

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

Carton

COOL AND HEAT 
menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-743
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
(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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-743-271 in 1 CARTON03/15/2023
174 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/15/2023
Labeler - AMERISOURCE BERGEN (007914906)
Registrant - Bionpharma Inc. (079637826)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114label(46122-743) , pack(46122-743) , analysis(46122-743) , manufacture(46122-743)

Revised: 1/2023
Document Id: f2bb0e98-51eb-2b92-e053-2995a90a3db2
Set id: f2bb0e8e-c4cd-0e8c-e053-2995a90a6df7
Version: 1
Effective Time: 20230120
 
AMERISOURCE BERGEN