ICE COLD ANALGESIC GEL- menthol and camphor (synthetic) gel 
Universal Distribution Center 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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Active Ingredients

Menthol             1.0%

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 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 hydroxytoluene, carbopol, colour brillient blue, creasmer RH 40, disodium EDTA, isopropyl alcohol, propylene glycol, purified water and sodium hydroxide

PRINCIPAL DISPLAY PANEL

ICE COLD ANALGESIC GEL

Topical Analgesic
NET WT.8 OZ (227g)

PRINCIPAL DISPLAY PANEL



ICE COLD ANALGESIC GEL 
menthol and camphor gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-013
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CARBOMER 934 (UNII: Z135WT9208)  
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:52000-013-17 127 g in 1 TUBE
2 NDC:52000-013-18 170 g in 1 TUBE
3 NDC:52000-013-13 170 g in 1 BOTTLE, PLASTIC
4 NDC:52000-013-14 227 g in 1 BOTTLE, PLASTIC
5 NDC:52000-013-15 300 g in 1 BOTTLE, PLASTIC
6 NDC:52000-013-16 500 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/15/2013
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
Name Address ID/FEI Business Operations
Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(52000-013)

Revised: 3/2013
Document Id: 149e60fd-1d2b-498e-9164-b37d82d91e5b
Set id: 422bd4a3-f03f-496e-b44f-d51885678baa
Version: 1
Effective Time: 20130315
 
Universal Distribution Center LLC