FDA.reportPublic FDA data

cool and heat pain relieving liquid

Manufacturer
Bionpharma Inc.
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:33

Label at a glance#

Productcool and heat pain relieving liquid
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

Temporarily relieves minor muscle and joint pain associated with arthritis simple backache muscle strains sprains bruises.

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 16%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor muscle and joint pain associated with

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises.

Warnings

WARNINGS SECTION

OTC - WHEN USING SECTION

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 SECTION

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

SPL UNCLASSIFIED SECTION

Flammable

  • Keep away from fire or flame

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate, Propylene Glycol, Purified Water, SD Alcohol 40 (30%), Triethanolamine

Questions & comments?

OTC - QUESTIONS SECTION

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

SPL UNCLASSIFIED SECTION

*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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*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)

cartoncarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-375-96cool and heat pain relieving liquid1 in 1 CARTONLIQUID12
69452-375-96cool and heat pain relieving liquid74 mL in 1 CONTAINERLIQUID742

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-375COOL AND HEAT PAIN RELIEVING LIQUID (MENTHOL) LIQUID [BIONPHARMA INC.]2Current NDC, Legacy NDC, 2 package rows20241225_ec6f59d8-45c5-46a0-e053-2995a90a239f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69452-37569452-375-96

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)132584PQMOIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MIACT
CAPSAICINS07O44R1ZMIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cool and heat pain relieving liquidMENTHOLBionpharma Inc.ec6f59d8-45c5-46a0-e053-2995a90a239f2024-12-23WarningsExact identifier
ndc (package): 69452-375-96
ndc (product): 69452-375
ndc11 (package): 69452037596
spl id: 29f91a1d-7cce-3cab-e063-6394a90a0274
spl set id: ec6f59d8-45c5-46a0-e053-2995a90a239f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.