ICE COLD ANALGESIC- menthol,camphor gel 
North & South Wholesalers 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

Active Ingredients

Menthol             1%

Camphor          0.5%

Purpose

Topical Analgesic

Uses

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

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

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

Keep out of the reach of children

If swallowed, get medical help or contact a poison control center right away

Directions

Inactive Ingredients

benzyl alcohol, butylated hydroxy toluene, carbopol, color brilient blue, creasmer RH-40, disodium EDTA, isopropyl alcohol, propylene glycol, purified water, sodium hydroxide.

PRINCIPAL DISPLAY PANEL

ICE COLD ANALGESIC GEL

Topical Analgesic

NET WT.8 OZ (227g)

label

ICE COLD ANALGESIC 
menthol,camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70201-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
BRILLANT BLUE (UNII: 1Y6J4O88C8)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70201-003-08227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/03/2015
Labeler - North & South Wholesalers LLC (004948495)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(70201-003)

Revised: 11/2015
Document Id: 241fd9f0-9016-4299-e054-00144ff8d46c
Set id: f3f2cf5e-7404-4be0-8e0f-a29b1cb2249c
Version: 2
Effective Time: 20151109
 
North & South Wholesalers LLC