Amar Ice

Dosage form: gel
Ingredients: Menthol 2.5g in 100g
Labeler: AMAR REMEDIES LIMITED
NDC Code: 41499-123

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.

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)

AMAR ICE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41499-123
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Camphor (Synthetic)0.7 g  in 100 g
MethylParaben Sodium 
PropylParaben Sodium 
Methyl Salicylate 
Propylene Glycol 
Phenoxyethanol 
Propyl Alcohol 
Water 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41499-123-01227 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2010
Labeler - AMAR REMEDIES LIMITED (677141751)

Revised: 04/2011
 
AMAR REMEDIES LIMITED

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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