KERATEK- menthol, methyl salicylate gel

KERATEK by

Drug Labeling and Warnings

KERATEK by is a Otc medication manufactured, distributed, or labeled by GERITREX CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

contact a Poison Control Center Immediately

STORAGE AND HANDLING

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

DOSAGE & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KERATEK 
menthol, methyl salicylate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-540
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	28 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-540-04	113 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/21/2013

Labeler - GERITREX CORP (112796248)

Registrant - GERITREX CORP (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
GERITREX CORP		112796248	manufacture(54162-540)