ICE COLD ANALGESIC GEL- menthol and camphor 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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Ice Cold Anagelsic Gel

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-013
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 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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52000-013-17127 g in 1 TUBE; Type 0: Not a Combination Product02/14/2022
2NDC:52000-013-18170 g in 1 TUBE; Type 0: Not a Combination Product02/14/2022
3NDC:52000-013-13170 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2022
4NDC:52000-013-14227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2022
5NDC:52000-013-15300 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2022
6NDC:52000-013-16500 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/15/2013
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-013)

Revised: 2/2022
Document Id: d882e2a1-eb18-30f1-e053-2a95a90aebdf
Set id: 422bd4a3-f03f-496e-b44f-d51885678baa
Version: 3
Effective Time: 20220221
 
Universal Distribution Center LLC