FDA Label for Povidone Iodine
View Indications, Usage & Precautions
Povidone Iodine Product Label
The following document was submitted to the FDA by the labeler of this product 1201258 Ontario Inc. O/a Nanz Pharma. 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.
Active Ingredients
5% Povidone Iodine Solution USP
Purpose:
Topical Antifungal
Uses:
For the treatment of athlete's foot, jock itch, and ring worm
For the effective relief of burning, cracking, discomfort, redness, scaling, soreness, and chafing that is associated with jock itch.
Warnings:
Do not use on children under 2 years of age unless directed by a doctor. For external use only. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks, disuse and consult a doctor. If irritation occurs or if there is no improvement within 2 weeks, discontinue and consult a doctor.
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help immediately or contact a Poison Control Center right away.
Storage:
Store in dry and dark place at temperature not exceeding 30C. Do not freeze
Povidone Iodine Label for all sizes
Inactive Ingredients:
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 400
Directions:
Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For athlete's foot: Pay special atto spaces between the toes; wear well-fitting, ventilated shoes, and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If the condition persists longer, consult a doctor. This product is not effective on the scalp or nails.
To prevent athlete's foot, wash the feet and dry them thoroughly. Apply a thin layer of the product to the feet once or twice daily (morning and/or night). Supervise children in the use of this product with special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
Stop Use And Ask Doctor If:
Irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.
Distributed By:
1201258 Ontario Inc. Nanz Pharma
575 Granite Court
Pickerin, Ontario
L1W 3K1
1201258 Ontario Inc. Na
Canada
Manufactured And Marketed By:
Nanz Pharma
575 Granite Ct.
Pickering,ON
L1W 3K1
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