Drug Facts
Active Ingredients Purpose
Menthol 16% Topical analgesic
Methyl Salicylate 28% Topical analgesic
Keratek
FDA Label NDC 54162-540
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Corp for the product Keratek (NDC 54162-540). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, uses, directions, warnings, inactive ingredients, otc - keep out of reach of children, storage and handling, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Label Of Bottle (Ktg)
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