KERATEK- menthol, methyl salicylate gel 
GERITREX CORP

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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KERATEK GEL

DRUG FACTS

Active Ingredients                            Purpose

Menthol 16%                          Topical analgesic

Methyl Salicylate 28%             Topical analgesic

USES

Temporarily retieves the minor aches and pains of muscles and joints associated with single

backache, arthritis, strains, bruises and sprains.

Directions

Use only as directed

Adults and children 12 years of age and older apply to affected area not more than 3 to 4 times daily

children under 12 years of age ask a doctor

Warnings

For external use only

Do not use on wounds of damaged skin or with a heating pad or on a child under 12 years of age with arthritis-like conditions.

Ask doctor before use if you have redness over the affected area.

When using this product

Avoid contact with eyes or mucous membranes do not bandage tightly

Stop use and ask a doctor if

condition worsens or symptoms persist for more than 7 days

symtoms clear up and occur again within a few days

excessive skin irritation occurs

Inactive Ingredients

Arnica, carbomer, cetyl alcohol, dmdm hydantoin, edetate disodium, lanolin, methyl paraben, paraffin wax, peg 40 hydrogenated castor oil,

peg 100 stearate, petrolatum, polygel w400, polysorbate 80, propyl paraben, purified water, stearic acid.

Keep out of reach of children to avoid accidental ingestion. if swallowed, get medical help or

contact a Poison Control Center Immediately

Store at 20' to 25'C (68' to 77'F)

Apply to affected area not more than 3 to 4 times daily.

Label of Bottle

KERATEK 
menthol, methyl salicylate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-540
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE28 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA (UNII: O80TY208ZW)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-540-04113 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/21/2013
Labeler - GERITREX CORP (112796248)
Registrant - GERITREX CORP (112796248)
Establishment
NameAddressID/FEIBusiness Operations
GERITREX CORP112796248manufacture(54162-540)

Revised: 10/2013
Document Id: c2b7282b-6a7c-4344-9694-a72ccc386c36
Set id: 5527b965-615b-4eff-8597-8c3e2e626f61
Version: 1
Effective Time: 20131021
 
GERITREX CORP