Otc - Active Ingredient
Active Ingredient:
Menthol USP 0.1%
Footscriptions Foot Repair
FDA Label NDC 70990-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Donegal Bay Ltd for the product Footscriptions Foot Repair (NDC 70990-002). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose:
External Analgesic
Indications & Usage
Uses:
Temporarily relieves pain and itching associated with skin irritations
Warnings
Warnings:
For external use only
When using this product, avoid contacting with eyes
Otc - Stop Use
Stop use and ask a doctor if condition worsens or if symptoms last for more than 7 days or clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Direction:
Adults and children 2 years and older: apply up to 3-4 times daily.
Under 2 years: ask a doctor
Wash and dry feet, apply liberally over feet, between toes, on bottoms of feet, and message until absorbed.
Inactive Ingredient
Inactive Ingredients:
Aloe Barbadenis Leaf Juice, Water, Mineral Oil, Glycerryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Cetearyl Alcohol, Polysorbate 60, Propylene Glycol, Stearic Acid, Hydrogenated Polyisobutene, Dimethicone, Triethanolamine, Salicylic Acid, Imidazlidinyl, Urea, Chondrus Crispus, Methylparaben, Propylparaben, Mentha Piperita (peppermint) Oil, Chloroxylenol, DMDM Hydantoin
Package Label.Principal Display Panel
Image Description (Footrepaircreamartwork2016)
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