ICE ANALGESIC- menthol gel 
Filo America

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 ANALGESIC GEL

ICE ANALGESIC GEL


Active Ingredient

Menthol 1.0%

Purpose

Topical Analgesic

Uses

Temporary relief:

minor muscles aches and pains

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

Consult a doctor and discontinue use

if condition worsens, persist 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

For the temporary relief of minor muscle aches and pains

see important warnings under "When using this product"

Inactive Ingredients

blue 1, camphor, carbomer, isopropyl alcohol, methylchoroisothiazolinone, methuylisothiazoline, sodium hydroxide, water

ICE Analgesic Gel

Net wt 8oz (227g)

DISTRIBUTED BY:

Filo America

P.O. Box 23592

Los  Angeles, CA 90023

Developed in USA, products in PRC

questions or concerns?

1.866.460.0322

ASSURED ICE COLD TOPICAL ANALGESIC GEL 8oz (33992-7994-8)

ICECOLD

ICE ANALGESIC 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
ALCOHOL (UNII: 3K9958V90M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50438-501-01227 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/05/2015
Labeler - Filo America (943873703)
Registrant - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture(50438-501)

Revised: 5/2015
Document Id: 10caa662-d984-4ada-8ae7-3df087cb3506
Set id: aa96561f-1641-4d45-a743-9322a6522978
Version: 1
Effective Time: 20150505
 
Filo America