Label: NANZ POVIDONE IODINE 5% SOLUTION- povidone iodine 5% solution liquid
-
NDC Code(s):
83254-050-01,
83254-050-02,
83254-050-05,
83254-050-10, view more83254-050-11, 83254-050-15, 83254-050-18, 83254-050-20, 83254-050-22, 83254-050-25, 83254-050-33, 83254-050-50, 83254-050-60, 83254-050-90
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose:
- Uses
-
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, discontinue use 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
- Manufactured and Marketed by:
-
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 attention to 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 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. Pay 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 A DOCTOR IF:
- Distributed by:
- Packagae Label
-
INGREDIENTS AND APPEARANCE
NANZ POVIDONE IODINE 5% SOLUTION
povidone iodine 5% solution liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83254-050 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 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) NONOXYNOL-9 (UNII: 48Q180SH9T) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) GLYCERIN (UNII: PDC6A3C0OX) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) WATER (UNII: 059QF0KO0R) POTASSIUM IODATE (UNII: I139E44NHL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83254-050-02 200 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2023 2 NDC:83254-050-05 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2023 3 NDC:83254-050-25 225 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2023 4 NDC:83254-050-01 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2023 5 NDC:83254-050-15 150 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2023 6 NDC:83254-050-10 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2023 7 NDC:83254-050-50 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2023 8 NDC:83254-050-60 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2023 9 NDC:83254-050-90 90 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2023 10 NDC:83254-050-20 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2023 11 NDC:83254-050-18 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2023 12 NDC:83254-050-11 30 mL in 1 POUCH; Type 0: Not a Combination Product 02/08/2023 13 NDC:83254-050-22 60 mL in 1 POUCH; Type 0: Not a Combination Product 02/08/2023 14 NDC:83254-050-33 90 mL in 1 POUCH; Type 0: Not a Combination Product 02/08/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M005 02/08/2023 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 label(83254-050) , manufacture(83254-050) , pack(83254-050)
