KERATEK

Dosage form: gel
Ingredients: MENTHOL 16g in 100g, METHYL SALICYLATE 28g in 100g
Labeler: GERITREX CORP
NDC Code: 54162-540

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.

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.

KERATEK 
menthol, methyl salicylate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-540
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL16 g  in 100 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE28 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA 
CETYL ALCOHOL 
DMDM HYDANTOIN 
EDETATE DISODIUM 
LANOLIN 
METHYLPARABEN 
PARAFFIN 
PEG-40 CASTOR OIL 
PEG-100 STEARATE 
PETROLATUM 
POLYSORBATE 80 
PROPYLPARABEN 
WATER 
STEARIC ACID 
Packaging
#Item CodePackage Description
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/FEIOperations
GERITREX CORP112796248manufacture(54162-540)

Revised: 10/2013
 
GERITREX CORP

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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