BLUE ICE TOPICAL ANALGESIC- menthol and camphor gel 
FOUR SEASONS TRADING INC

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.

----------

Blue Ice Topical Analgesic Gel

Active Ingredients

Menthol             1.0%

Camphor            0.5%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor pains and aches of your muscles and joints associated with:

Warnings

For external use only. Avoid contact with eyes.

Ask a doctor before use if you have cough associated with :

When using this product, do not

Do not use with heating devices or pads.

Consult a doctor and discontinue use if condition worsens, persists for more than 1 week or tends to recur.

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions: see important warnings under “When using this product”

adults and children 2 years and over:

Inactive Ingredients

Aqua, Isopropyl Alcohol, Propylene Glycol, Carbopol, PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide , Disodium EDTA, Benzyl Alcohol, BHT & FD&C Blue No.1

PRINCIPAL DISPLAY PANEL

BLUE ICE TOPICAL ANALGESIC GEL

NET WT. 8 OZ (227g)


label

BLUE ICE TOPICAL ANALGESIC 
menthol and camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69274-004
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).5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69274-004-15127 g in 1 TUBE
2NDC:69274-004-16170 g in 1 TUBE
3NDC:69274-004-13170 g in 1 BOTTLE, PLASTIC
4NDC:69274-004-17227 g in 1 BOTTLE, PLASTIC
5NDC:69274-004-18300 g in 1 BOTTLE, PLASTIC
6NDC:69274-004-19500 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/25/2014
Labeler - FOUR SEASONS TRADING INC (169331464)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(69274-004)

Revised: 11/2014
Document Id: 08b343dd-3ca9-6ff6-e054-00144ff88e88
Set id: 34b958a4-807e-46fe-9616-75732587c5f8
Version: 1
Effective Time: 20141125
 
FOUR SEASONS TRADING INC