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KERATEK

Geritrex Corp
Geritrex Corp

KERATEK GEL


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

KERATEK

MENTHOL, METHYL SALICYLATE GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54162-540
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 16 g
methyl salicylate METHYL SALICYLATE 28 g

Inactive Ingredients

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2013-10-21


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Be sure to consult your doctor before taking any medication!
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