BETADINE- povidone-iodine liquid 
Xttrium Laboratories, Inc.

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7.5% Betadine Surgical Scrub 4oz and 1 gallon

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:

B. Antiseptic hand wash:

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

■ 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

7.5% Betadine Surgical 4oz7.5% Betadine surgical 1 gallon

BETADINE 
povidone-iodine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-0151
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.075 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0116-0151-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/07/2024
2NDC:0116-0151-013780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/07/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00311/07/2024
Labeler - Xttrium Laboratories, Inc. (007470579)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.007470579manufacture(0116-0151)

Revised: 11/2024
Document Id: 26573a6d-2e4b-3841-e063-6294a90a291a
Set id: 26573a6d-2e4a-3841-e063-6294a90a291a
Version: 1
Effective Time: 20241107
 
Xttrium Laboratories, Inc.