FDA Label for Keratek

View Indications, Usage & Precautions

Keratek Product Label

The following document was submitted to the FDA by the labeler of this product Geritrex Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


Otc - 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.


Package Label.Principal Display Panel




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