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NDC 69452-0375-96 cool and heat pain relieving liquid 16 mg/100mL Details

cool and heat pain relieving liquid 16 mg/100mL

cool and heat pain relieving liquid is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Bionpharma Inc.. The primary component is MENTHOL.

Product Information

NDC	69452-0375
Product ID	69452-375_ec6f2790-9d24-62cd-e053-2995a90a46dd
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	cool and heat pain relieving liquid
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	16
Active Ingredient Units	mg/100mL
Substance Name	MENTHOL
Labeler Name	Bionpharma Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69452-0375-96 (69452037596)

Pricing Information	N/A
NDC Package Code	69452-375-96
Billing NDC	69452037596
Package	1 CONTAINER in 1 CARTON (69452-375-96) / 74 mL in 1 CONTAINER
Marketing Start Date	2022-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ec6f59d8-45c5-46a0-e053-2995a90a239f Details

Active ingredient

Menthol 16%

Purpose

Topical analgesic

Uses

Temporarily relieves minor muscle and joint pain associated with

arthritis
simple backache
muscle strains
sprains
bruises.

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

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)

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

*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)

INGREDIENTS AND APPEARANCE

COOL AND HEAT PAIN RELIEVING LIQUID

menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69452-375
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69452-375-96	1 in 1 CARTON	11/01/2022
1		74 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	11/01/2022

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