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Name:Blue Ice Analgesic
Manufacturer:Delon Laboratories (10) Ltd
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

BLUE ICE ANALGESIC  - menthol gel 
Delon Laboratories (1990) Ltd

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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Drug Facts

Active Ingredient / Purpose


Menthol 2.0%

Uses


    Temporary relief of minor aches and pains in
  • muscles and joints

Directions

  • Put a small amount onto your palms and rub hands together until dry.

Warnings

  • For external use only. Avoid contact with eyes and mucous membranes.

    


When using this product do not:

  • use with heating pads or heating devices
  • use, pour, spill, or store near open flame
  • use with other creams, sprays or liniments
  • apply to damaged skin or wounds - Bandage area tightly
To do so may result in excessive skin irritation or skin burn.

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


If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. If you have sensitive skin consult a physician. If skin irritation develops, discontinue use and seek the advice of a physician before using this product.

Directions

  • See important warnings under when using this product
  • Do not apply to children under 2 years of age, unless advised by a physician.
  • Adults and children over 2 years and older: Apply liberally to painful area and massage until gel is absorbed into the skin. Repeat 3 to 4 times daily.

Inactive Ingredients

 Deinoized Water, Isopropyl Alcohol, Carbomer, Thymol, Ammonium Hydroxide, Sodium Hydroxide, Magnesium sulfate, FDC Blue 1

mm1Blue Ice



BLUE ICE ANALGESIC 
menthol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61734-021
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Menthol (Menthol) Menthol 2.0 g  in 100 g
Product Characteristics
Color blue Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61734-021-01 100 g in 1 BOTTLE, PUMP None
2 NDC:61734-021-02 113.56 g in 1 CONTAINER None
3 NDC:61734-021-03 227 g in 1 CONTAINER None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part348 05/07/2010

Labeler - Delon Laboratories (1990) Ltd (248364184)

Revised: 07/2010 Delon Laboratories (1990) Ltd



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


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