BLUE ICE by JT Cosmetics and Chemicals BLUE ICE- menthol gel

BLUE ICE by

Drug Labeling and Warnings

BLUE ICE by is a Otc medication manufactured, distributed, or labeled by JT Cosmetics and Chemicals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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).

STORAGE AND HANDLING

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

INGREDIENTS AND APPEARANCE

BLUE ICE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69859-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69859-002-76	227 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/23/2015

Labeler - JT Cosmetics and Chemicals (650884849)

Establishment
Name	Address	ID/FEI	Business Operations
JT Cosmetics and Chemicals		650884849	manufacture(69859-002)