BLUE ICE- menthol gel 
JT Cosmetics and Chemicals

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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BLUE ICE

Diva Blue Ice is a cool, greaseless pain reliever. It penetrates deep into skin for fast, temporary relief of minor aches and pains in muscles and joints. It provides cooling, soothing relief that lasts for hours.

Drug Facts

Active Ingredients

Menthol 2%

Purpose

Topical Analgesic

Keep out of reach of children.

Usage:

Provides temporary relief of minor aches and pains in muscles and joints associated with simple backache, strains, sprains, arthritis and sports injuries.

Warning

For External use only. Not for internal use.

Use only as directed. Avoid contact with eyes or mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free from any creams, ointments, sprays or liniment. Do not bandage.

Do not use with heating pads or heating devices.

If condition worsens of symptoms persist for more than 7 days or if symptoms disappear and occur again within a few days, discontinue use and consult a physician. If you have sensitive skin, consult a physician before use. If skin irritation develops, discontinue use and consult a physician. If you are pregnant or nursing a baby, consult your doctor before use.

Direction

Clean skin of all other lotions, cream ointments, liniment or sprays. Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times daily. No protective cover needed. Do not apply to children under 2 years of age.

Inactive Ingredients:

Water, Isopropyl Alcohol, Camphor, Carbomer, Sodium Hydroxide, Methylchloroisothiazolinone & Methylisothiazolinone, Blue 1 (CI 42090).

Do not use, store, pour or spill near heat or open flame. Store in a cool, dry place and keep lid tightly closed.

Distributed by

JMD ALL STAR IMPEX INC.,

Edison, NJ - 08817

Made in India.

Neutral Code : GUJ/GA/1676

Packaging

blueicelbl

BLUE ICE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69859-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69859-002-76227 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/23/2015
Labeler - JT Cosmetics and Chemicals (650884849)
Establishment
NameAddressID/FEIBusiness Operations
JT Cosmetics and Chemicals650884849manufacture(69859-002)

Revised: 6/2015
Document Id: a181e8f7-f2e9-4e0c-97c2-727857098437
Set id: 81d53f62-c9db-4cd1-9f26-29c06d923736
Version: 1
Effective Time: 20150601
 
JT Cosmetics and Chemicals