ICE COLD ANALGESIC- menthol 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 Ingredient

Menthol             1.25%

Purpose

Topical Analgesic

Uses

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

Other information

Inactive Ingredients

benzyl alcohol, BHT, camphor, carbopol, disodium EDTA, FD&C blue no.1, isopropyl alcohol, PEG-40 hydrogenated castor oil, propylene glycol, sodium hydroxide, water.

PRINCIPAL DISPLAY PANEL

ICE COLD ANALGESIC GEL

Topical Analgesic

NET WT.8 OZ (227g)

label

ICE COLD ANALGESIC 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70201-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70201-005-08227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/19/2018
Labeler - North & South Wholesalers LLC (004948495)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(70201-005)

Revised: 8/2018
Document Id: 73c52e7b-1903-2f97-e053-2991aa0a8af7
Set id: 32bdc9e2-9e4c-4607-afeb-6abd39051676
Version: 1
Effective Time: 20180819
 
North & South Wholesalers LLC