COOL AND HEAT PAIN RELIEVING LIQUID- menthol liquid 
Bionpharma Inc.

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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cool & heat pain relieving liquid

Active ingredient

Menthol 16%

Purpose

Topical analgesic

Uses

Temporarily relieves minor muscle and joint pain associated with

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 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.

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

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

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)

*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

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

2.5 fl oz (74mL)

carton

COOL AND HEAT PAIN RELIEVING LIQUID 
menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-375
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
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
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:69452-375-961 in 1 CARTON11/01/2022
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 finalpart34811/01/2022
Labeler - Bionpharma Inc. (079637826)
Registrant - Bionpharma Inc. (079637826)

Revised: 11/2022
Document Id: ec6f2790-9d24-62cd-e053-2995a90a46dd
Set id: ec6f59d8-45c5-46a0-e053-2995a90a239f
Version: 1
Effective Time: 20221101
 
Bionpharma Inc.