BETADINE- 10% povidone-iodine liquid

Betadine by

Drug Labeling and Warnings

Betadine by is a Otc medication manufactured, distributed, or labeled by Xttrium Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Povidone-iodine, 10%

Purpose

Antiseptic

Uses

Patient pre-operative skin preparation
■ for preparation of the skin prior to surgery
■ helps reduce bacteria that potentially can cause skin infection

Warnings

For external use only
Do not use ■ in the eyes ■ if you are allergic to povidone-iodine or any
other ingredients in this preparation
When using this product
■ prolonge exposure to wet solution may cause irritation or, rarely severe skin
reactions ■ in pre-operative prepping, avoid "pooling" beneath the patient
Stop use and ask a doctor if
■ irritation, sensitization, or allergic reaction occurs and lasts for 72 hours.
These may be signs of a serious condition.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

■ single use only ■ clean the operative site prior to surgery
■ apply product and allow to dry ■ may be covered with a sterile bandage

Other information

■ store in original container

■ store at 25'C (77'F); excursions permitted between 15'-30'C (59'-86'F)

Inactive Ingredient

citric acid, disodium phosphate, glycerin, nonoxynol-9, purified water, sodium hydroxide

Questions?

1-833-288-2684

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BETADINE 
10% povidone-iodine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0116-0150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0116-0150-05	14.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/05/2024
2	NDC: 0116-0150-01	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/05/2024
3	NDC: 0116-0150-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/05/2024
4	NDC: 0116-0150-09	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/05/2024
5	NDC: 0116-0150-17	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/05/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	11/05/2024

Labeler - Xttrium Laboratories, Inc. (007470579)