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

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

Other information

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:41499-123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Camphor (Synthetic) (UNII: 5TJD82A1ET) 0.7 g  in 100 g
MethylParaben Sodium (UNII: CR6K9C2NHK)  
PropylParaben Sodium (UNII: 625NNB0G9N)  
Methyl Salicylate (UNII: LAV5U5022Y)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Propyl Alcohol (UNII: 96F264O9SV)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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: 4/2011
Document Id: dfe38d4d-50ba-41f2-afbd-772970bc3cff
Set id: 1ca34e8a-959d-4e48-b89a-e42ca0df46aa
Version: 3
Effective Time: 20110414
 
AMAR REMEDIES LIMITED