BETADINE- 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, 7.5%

Purpose

Antiseptic

Uses

■ for preparation of the skin prior to surgery
■ helps to reduce bacteria that potentially can cause skin infection
■ for handwashing to reduce bacteria on the skin
■ significantly reduces the number of microorganisms on the hands forearms prior to surgery or patient care

Warnings

For external use only
Do not use ■ in the eyes
When using this product ■ prolonged 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 and redness develop
■ in rare instances of local irritation or sensitivity

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

A. Surgical hand scrub:

• wet hands with water
• spread about 5 cc (1 teaspoonful) of Scrub over both handsand forearms
• without adding more water, scrub thoroughly for 2 1/2 to3 minutes
• use a sponge if desired. Clean thoroughly under fingernails.
• add a little water and develop copious suds. Rinse thoroughlyunder running water.
• repeat the entire procedure using another 5 cc of Scrub

B. Antiseptic hand wash:

• wet hands with water and pour about 5 cc of Scrub on hands
• rub hands vigorously together for at least 15 seconds, coveringall surfaces
• rinse and dry with a disposable towel

C. Patient pre-operative skin preparation:
■ single use only

■ wet skin with water
■ apply Scrub (1 cc is sufficient to cover an area of 20-30 square inches),
develop lather and scrub thoroughly for about 5 minutes
■ rinse off using sterile gauze saturated with water
■ the area may then be painted with BETADINE Solution and allowed to dry

OTHER SAFETY INFORMATION

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

Inactive Ingredients

ammonium nonxynol-4 sulfate,
nonoxynol-9, purified water, sodium hydroxide

Questions?

1-833-288-2684

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BETADINE 
povidone-iodine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0116-0151
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.075 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0116-0151-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/07/2024
2	NDC: 0116-0151-01	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/07/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	11/07/2024

Labeler - Xttrium Laboratories, Inc. (007470579)

Registrant - Xttrium Laboratories, Inc. (007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc.		007470579	manufacture(0116-0151)