UNIVERSAL ICE COLD ANALGESIC- menthol gel 
Anicare Pharmaceuticals Pvt. Ltd.

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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UNIVERSAL ICE COLD ANALGESIC GEL

Active Ingredients

Menthol 1.25%

Purpose

Topical Analgesic

Uses

Temporary relieves 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 doctor if

If pregnant or breast-feeding,

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Inactive ingredients

Water, Propylene glycol, Isopropyl alcohol, Carbomer, Sodium hydroxide, Benzyl alcohol, Edetate Disodium, Butylated hydroxytoluene, Camphor, Fd&c Blue No. 1

PRINCIPAL DISPLAY PANEL

ICE COLD
ANALGESIC GEL
8 FL.OZ (237 ml)
PRINCIPAL DISPLAY PANEL


UNIVERSAL ICE COLD ANALGESIC 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47046-159
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
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:47046-159-01237 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2020
Labeler - Anicare Pharmaceuticals Pvt. Ltd. (916837425)
Registrant - Anicare Pharmaceuticals Pvt. Ltd. (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd.916837425manufacture(47046-159)

Revised: 12/2020
Document Id: b65a6987-b7a5-0550-e053-2995a90ae7dc
Set id: b65a33b5-db06-e0ae-e053-2a95a90af0ea
Version: 1
Effective Time: 20201213
 
Anicare Pharmaceuticals Pvt. Ltd.