HOT ICE SOOTHING ANALGESIC- camphor and menthol gel 
Quality Care Distributors LLC

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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Ice Cold Analgesic Gel

Drug Facts

Active Ingredients   

Menthol 1%

Camphor 0.5%   

Purpose

Topical analgesic

Uses   

for the temporary relief of minor aches and pains in muscles and joins associated with

Warnings

For external use only.

Do not use

  • with other topical pain relievers
  • with heating pads or heating devices

When using this product

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

Stop use and ask doctor if

  • condition worsen
  • symptoms last more than 7 days or clear up and occurs again with 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 way.

Directions

Inactive ingredients

Benzyl alcohol, butylated hyderoxy toluene, carbopol, colour brilliant blue, creasmer RH 40, disodium Edta, isopropyl alcohol, propylene glycol, purified water, sodium hydroxide

Principal Display Panel

FamilyCare
ICE

COLD

ANALGESIC GEL
NET WT. 8 OZ. (227 g)

Principal Display Panel
FamilyCare 
ICE COLD ANALGESIC GEL

HOT ICE SOOTHING ANALGESIC 
camphor and menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52271-159
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.27 g  in 227 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1.14 g  in 227 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CARBOMER 934 (UNII: Z135WT9208)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52271-159-00227 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/21/2009
Labeler - Quality Care Distributors LLC (961937112)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd.916837425MANUFACTURE

Revised: 7/2010
Document Id: 83734ee7-58a7-401b-b921-fab10197227a
Set id: f753f10e-6ed8-4ad5-bb6c-7042461fc36d
Version: 2
Effective Time: 20100731
 
Quality Care Distributors LLC