XTT Betadine 10% Professional

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]

BETADINE- 10% povidone-iodine liquid 
Xttrium Laboratories, Inc.

----------

XTT Betadine 10% Professional

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

Betadine 10 DF

BETADINE 
10% povidone-iodine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0116-0150
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0116-0150-0514.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2024
2NDC: 0116-0150-013780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2024
3NDC: 0116-0150-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2024
4NDC: 0116-0150-09237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2024
5NDC: 0116-0150-17473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00311/05/2024
Labeler - Xttrium Laboratories, Inc. (007470579)

Revised: 5/2025
 

Trademark Results [Betadine]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BETADINE
BETADINE
90851747 not registered Live/Pending
Avrio Health L.P.
2021-07-27
BETADINE
BETADINE
75438619 2289922 Live/Registered
AVRIO HEALTH L.P.
1998-02-23
BETADINE
BETADINE
75429382 not registered Dead/Abandoned
PURDUE FREDERICK COMPANY, THE
1998-02-05
BETADINE
BETADINE
75429381 2649701 Dead/Cancelled
PURDUE FREDERICK COMPANY, THE
1998-02-05
BETADINE
BETADINE
75429376 2225977 Live/Registered
AVRIO HEALTH L.P.
1998-02-05
BETADINE
BETADINE
75000809 1984349 Dead/Cancelled
PURDUE FREDERICK COMPANY, THE
1995-10-02
BETADINE
BETADINE
74711684 1984228 Dead/Cancelled
PURDUE FREDERICK COMPANY, THE
1995-08-07
BETADINE
BETADINE
74596982 1982032 Dead/Cancelled
Purdue Frederick Company, The
1994-11-09
BETADINE
BETADINE
73839535 1601849 Live/Registered
PURDUE FREDERICK COMPANY
1989-11-15
BETADINE
BETADINE
73779372 1559504 Live/Registered
PURDUE FREDERICK COMPANY, THE
1989-02-06
BETADINE
BETADINE
73107412 1069261 Dead/Expired
PURDUE FREDERICK COMPANY, THE
1976-11-22
BETADINE
BETADINE
73072465 1059771 Dead/Expired
PURDUE FREDERICK COMPANY, THE
1975-12-22

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.