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Name:Amar Ice
Manufacturer:Amar Remedies Limited
Category:Over-the-counter (OTC) Marketed Drugs


Amar ICE GEL

AMAR ICE - menthol gel 
AMAR REMEDIES LIMITED

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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Amar
ICE GEL

Drug Facts

Active Ingredient

Menthol 2.5%

Purpose

Topical analgesic

Uses

  • temporarily relieves minor aches and pains of muscles and joints associated with:
    • arthritis
    • bruises
    • simple backache
    • sport injuries
    • strains
    • sprains
  • provides cooling penetrating relief

Warnings

For external use only

Do not use

  • with heating pads or heating devices

When using this product

  • do not use in or near the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • redness or irritation develops

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • clean affected area before applying product
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Other information

  • store in a cool place
  • keep lid tightly closed
  • do not use, pour, spill or store near heat or open flame

Inactive ingredients

Water, Camphor, Carbopol, Methyl Paraben Sodium, Propyl Paraben Sodium, Wintergreen oil, Propylene Glycol, Phenoxy ethanol, ISO Propyl alcohol, Sodium Hydroxide, Cl 42090.

PRINCIPAL DISPLAY PANEL - 227 g Jar Label

Amar

ICE GEL

Net Wt 8 oz (227g)

Principal Display Panel - 227 g Jar Label

AMAR ICE 
menthol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41499-123
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Menthol (Menthol) Menthol 2.5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
Camphor (Synthetic) 0.7 g  in 100 g
MethylParaben Sodium  
PropylParaben Sodium  
Methyl Salicylate  
Propylene Glycol  
Phenoxyethanol  
Propyl Alcohol  
Water  
Product Characteristics
Color BLUE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41499-123-01 227 g in 1 JAR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 05/01/2010

Labeler - AMAR REMEDIES LIMITED (677141751)

Revised: 04/2011 AMAR REMEDIES LIMITED



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


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