Active Ingredient
Menthol 16%
Cool And Heat Pain Relieving Liquid
FDA Label NDC 69452-375
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bionpharma Inc. for the product Cool And Heat Pain Relieving Liquid (NDC 69452-375). 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, otc - when using, otc - stop use, other, otc - keep out of reach of children, 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
Otc - When Using
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.
Otc - Stop Use
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
Other
Flammable
- Keep away from fire or flame
*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Icy Hot®.
actual size
package containes one bottle
DISTRIBUTED BY:
Bionpharma Inc., Princeton, NJ 08540
L0000588
R03/22
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
*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)
Carton (Carton)
* Please review the disclaimer below.
