Label: FIRST AID ONLY POVIDONE-IODINE ANTISEPTIC- povidone-iodine swab
- NDC Code(s): 0924-8112-00, 0924-8112-01, 0924-8112-02, 0924-8112-03
- Packager: Acme United Corporation
- This is a repackaged label.
- Source NDC Code(s): 65517-0034
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 January 7, 2020
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- Official Label (Printer Friendly)
- Active Ingredient:
- Purpose:
- Use:
- Warnings:
- DO NOT USE
- Directions:
- Other Information:
- Inactive Ingredients:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FIRST AID ONLY POVIDONE-IODINE ANTISEPTIC
povidone-iodine swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-8112(NDC:65517-0034) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16) NONOXYNOL-10 (UNII: K7O76887AP) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) POTASSIUM IODIDE (UNII: 1C4QK22F9J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0924-8112-01 10 in 1 CARTON 01/07/2020 1 0.5 mL in 1 POUCH; Type 0: Not a Combination Product 2 NDC:0924-8112-00 0.5 mL in 1 POUCH; Type 0: Not a Combination Product 01/07/2020 3 NDC:0924-8112-02 50 in 1 CARTON 01/07/2020 3 0.5 mL in 1 POUCH; Type 0: Not a Combination Product 4 NDC:0924-8112-03 100 in 1 CARTON 01/07/2020 4 0.5 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 01/07/2020 Labeler - Acme United Corporation (001180207) Establishment Name Address ID/FEI Business Operations Acme United Corporation 045924339 relabel(0924-8112) , repack(0924-8112) Establishment Name Address ID/FEI Business Operations Acme United Corporation 080119599 relabel(0924-8112) , repack(0924-8112)