Label: HALODINE ORAL ANTISEPTIC- povidone-iodine spray
- NDC Code(s): 78371-401-01
- Packager: Halodine Llc
- 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 14, 2020
If you are a consumer or patient please visit this version.
- Drug Facts
- Active Ingredient
- INDICATIONS & USAGE
Warnings For external use only.
Do not use • If allergic to iodine • In the eyes • On children less than 3 years old • For more than 7 days unless directed by a dentist or doctor Stop use and promptly ask your dentist or doctor if sore mouth symptoms do not improve within 7 days, if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops.
DOSAGE & ADMINISTRATION
Directions For oral antisepsis in adults and children 3 years of age and older:
1. Press down pump completely and spray twice into mouth. 2. Swish vigorously in mouth for 15 seconds. 3. Slightly lift chin and tilt head back to gargle. Spit out excess. Children under 3 years of age: Consult a dentist or doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
HALODINE ORAL ANTISEPTIC
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78371-401 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 1.25 g in 100 mL Inactive Ingredients Ingredient Name Strength HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78371-401-01 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/01/2020 Labeler - Halodine Llc (117526113)