Label: BETADINE DRY POWDER- povidone-iodine aerosol, spray
- NDC Code(s): 67618-165-01
- Packager: Avrio Health L.P.
- 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.
Updated October 1, 2020
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- Drug Facts
Warnings For external use only
Extremely Flammable Do not use near heat, flame or while smoking. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120⁰F. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal
Do not use
- in or near eyes
- over large areas of the body
- if you are allergic to povidone-iodine or any other ingredients in this preparation
When using this product
- do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor.
Stop use and ask a doctor if
- the condition persists or gets worse
- you need to use this product for more than 1 week
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
BETADINE DRY POWDER
povidone-iodine aerosol, spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67618-165 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE .05 mg in 1 mL Inactive Ingredients Ingredient Name Strength ISOBUTANE (UNII: BXR49TP611) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PROPANE (UNII: T75W9911L6) METHOXYFLURANE (UNII: 30905R8O7B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67618-165-01 56.7 mL in 1 CAN; Type 0: Not a Combination Product 06/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/15/2020 Labeler - Avrio Health L.P. (141916531) Registrant - Purdue Pharma LP (932323652) Establishment Name Address ID/FEI Business Operations TRI-PAC, INC. 020844956 MANUFACTURE(67618-165) , PACK(67618-165)