Label: POVIDONE IODINE- povinanz ointment ointment
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NDC Code(s):
83254-500-01,
83254-500-05,
83254-500-10,
83254-500-11, view more83254-500-15, 83254-500-22, 83254-500-50, 83254-500-55, 83254-500-60, 83254-500-90
- Packager: 1201258 Ontario Inc. O/A Nanz Pharma
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 18, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose:
- Uses:
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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
- Storage:
- Inactive Ingredients:
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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:
- Distributed by:
- Manufactured and Marketed by:
- Label
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INGREDIENTS AND APPEARANCE
POVIDONE IODINE
povinanz ointment ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83254-500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 5 g in 100 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83254-500-50 150 g in 1 TUBE; Type 0: Not a Combination Product 05/04/2023 2 NDC:83254-500-10 100 g in 1 TUBE; Type 0: Not a Combination Product 05/04/2023 3 NDC:83254-500-90 90 g in 1 TUBE; Type 0: Not a Combination Product 05/04/2023 4 NDC:83254-500-60 60 g in 1 TUBE; Type 0: Not a Combination Product 05/04/2023 5 NDC:83254-500-01 10 g in 1 TUBE; Type 0: Not a Combination Product 05/04/2023 6 NDC:83254-500-15 15 g in 1 TUBE; Type 0: Not a Combination Product 05/04/2023 7 NDC:83254-500-05 5 g in 1 TUBE; Type 0: Not a Combination Product 05/04/2023 8 NDC:83254-500-11 1 g in 1 POUCH; Type 0: Not a Combination Product 05/04/2023 9 NDC:83254-500-22 2 g in 1 POUCH; Type 0: Not a Combination Product 05/04/2023 10 NDC:83254-500-55 5 g in 1 POUCH; Type 0: Not a Combination Product 05/04/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M005 05/04/2023 Labeler - 1201258 Ontario Inc. O/A Nanz Pharma (256906595) Registrant - 1201258 Ontario Inc. O/A Nanz Pharma (256906595) Establishment Name Address ID/FEI Business Operations 1201258 Ontario Inc. O/A Nanz Pharma 256906595 manufacture(83254-500) , pack(83254-500) , label(83254-500)
