GNP Cool & Heat

Manufacturer
AMERISOURCE BERGEN | Bionpharma Inc. | Pharma Nobis, LLC
Effective date
2026-05-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:57:06

Label at a glance#

ProductCool and Heat
Active ingredientMENTHOL
Label structure12 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

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

OTC - STOP USE SECTION

▪ 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)

Carton label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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
46122-743-27Cool and Heat1 in 1 CARTONLIQUID14
46122-743-27Cool and Heat74 mL in 1 CONTAINERLIQUID744

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
46122-74346122-743-27

Ingredients#

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

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

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 HeatMENTHOLAMERISOURCE BERGENf2bb0e8e-c4cd-0e8c-e053-2995a90a6df72026-05-11WarningsExact identifier
ndc (package): 46122-743-27
ndc (product): 46122-743
ndc11 (package): 46122074327
spl id: 518f947e-eb42-5fad-e063-6294a90a9656
spl set id: f2bb0e8e-c4cd-0e8c-e053-2995a90a6df7

Reported adverse events (FAERS/openFDA)#

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