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, 0.5%

Purpose

Antiseptic

Warning

Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high
fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than
2 days or administer to children under 3 years of age unless directed by a doctor.
Do not use this product

■ for more than 7 days unless directed by a dentist or doctor

■ if you are allergic to povidone-iodine or any othe ringredients in this product

■ if you have any thyroid condtions
When using this product

■ do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor

■ do not swallow

■ do not use with hydrogen peroxide
Stop use and ask a doctor

■ symptoms do not improve in 7 days

■ irritation, pain, or redness persists or worsens

■ swelling, rash, or fever develops
If pregnant or breast-feeding, ask a health professional before use.

INDICATIONS & USAGE

For the temporary relief of occasional sore throat

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case more than used for gargling is accidentally swallowed, get medical
help or contact a Poison Control Center right away.

Directions

DO NOT SWAllOW

Adults and children12 years and older:

■ Gargle with 10 ml full strength for 30 seconds, then spit out

■ Use only with dosing cup provided

■ Use up to 4 times daily
Children under 12: Do not use.

Other information

■ store at 25°F (77°F); excursions permitted between 15°-30°C (59°-86°F)
■ may stain clothing or dental work
■ avoid contact with jewelry, especially silver

Inactive Ingredients

citric acid, flavor, glycenn, propylene glycol, puritied water, saccharin sodium,
sodium hydroxide.

Questions or comments?

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: 0116-0181
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.05 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0116-0181-08	237 mL in 1 BOTTLE; 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	M022	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(0116-0181)