Blue Ice by JMD All Star Impex Inc / Steller Mercantile Pvt.Ltd. BLUE ICE- menthol gel

Blue Ice by

Drug Labeling and Warnings

Blue Ice by is a Otc medication manufactured, distributed, or labeled by JMD All Star Impex Inc, Steller Mercantile Pvt.Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient
Menthol 2.0%

PURPOSE

Purpose
External pain reliever

INDICATIONS & USAGE

Uses
Temporary relief of minor pains of muscles and joints associated with

• Simple back ache
  
• Arthritis
• Sprains, strains or bruises
  

WARNINGS

Warning
For external use only. Avoid contact with eyes

DO NOT USE

Do not use

• Internally
• With heating pads or devices
• On wounds or damaged skin
  

ASK DOCTOR

Ask doctor before use if you have sensitive skin

WHEN USING

When using this product

• Use only as directed
  
• Do not bandage tightly
• Avoid contact with eyes and mucus membranes
  

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately

INDICATIONS & USAGE

Direction

• Adult and children 2 years of age and older. Clean skin thoroughly. Apply liberally to affected area not more than 3-4 times daily. No protective cover needed.
• May be used with ice packs
• May be used with wet or dry bandage, but wrap loosely
• Children under 2 years of age, consult a doctor
  

SPL UNCLASSIFIED SECTION

Other Information store between 59-85F (15-30C)

• Keep tightly closed
• Do not use, pour, spill or store near heat or open flames
  

INACTIVE INGREDIENT

Other Ingredients Carbomer 940, FDC Blue No. 1, Isopropyl Alcohol, Propylene Glycol, Purified Water, Sodium Hydroxide,

PRINCIPAL DISPLAY PANEL

Package Label

INGREDIENTS AND APPEARANCE

BLUE ICE  
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51444-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51444-002-76	216 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/15/2010

Labeler - JMD All Star Impex Inc (962316662)

Establishment
Name	Address	ID/FEI	Business Operations
Steller Mercantile Pvt.Ltd.		650493005	manufacture