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Name:Blue Ice
Manufacturer:Jmd All Star Impex Inc
Category:Over-the-counter (OTC) Marketed Drugs


BLUE ICE   - menthol gel 
JMD All Star Impex Inc

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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Active Ingredient
Menthol 2.0%


Purpose
External pain reliever

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

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

Warning
For external use only. Avoid contact with eyes



Do not use

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

Ask doctor before use if you have sensitive skin

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

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

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

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

Other Information store between 59-85F (15-30C)
  • Keep tightly closed
  • Do not use, pour, spill or store near heat or open flames

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

Package Label

image of package label


BLUE ICE  
menthol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51444-002
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Menthol (Menthol) Menthol 2 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C  
FD&C BLUE NO. 1  
ISOPROPYL ALCOHOL  
PROPYLENE GLYCOL  
WATER  
SODIUM HYDROXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51444-002-76 216 g in 1 JAR None

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 Operations
Steller Mercantile Pvt.Ltd. 650493005 manufacture

Revised: 05/2010 JMD All Star Impex Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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