Gnp Cool & Heat

Gnp Cool & Heat
SPL v2
SPL
SPL Set ID f2bb0e8e-c4cd-0e8c-e053-2995a90a6df7
Route
TOPICAL
Published
Effective Date 2023-03-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (16 mg)
Inactive Ingredients
(c10-c30)alkyl Methacrylate Ester Propylene Glycol Trolamine Alcohol Capsaicin Isopropyl Myristate Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-15

Description

Menthol 16%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 16%

Uses

temporarily relieves minor muscle and joint pain associated with ▪ arthritis ▪ simple backache ▪ muscle strains ▪ sprains ▪ bruises

Section 42229-5

Flammable ▪ Keep away from fire or flame

Section 50565-1

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

Section 53414-9

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

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.

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

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

Active Ingredient

Menthol 16%

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)

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


Structured Label Content

Uses

temporarily relieves minor muscle and joint pain associated with ▪ arthritis ▪ simple backache ▪ muscle strains ▪ sprains ▪ bruises

Section 42229-5 (42229-5)

Flammable ▪ Keep away from fire or flame

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

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

Purpose

Topical analgesic

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.

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

Carton Label (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

Active Ingredient (Active ingredient)

Menthol 16%

Inactive Ingredients (Inactive ingredients)

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

Questions & Comments? (Questions & comments?)

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

Stop Use and Ask A Doctor (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)