Active Ingredient
Menthol 16%
Cool And Heat Liquid
FDA Label NDC 46122-743
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Cool And Heat (NDC 46122-743). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, stop use and ask a doctor, other, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Other
Flammable ▪ Keep away from fire or flame
Otc - 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.
Otc - 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
Carton (Gnp Carton)
* Please review the disclaimer below.
