BIOTRONIX HEALTHCARE- povidone iodine sponge

Biotronix Healthcare by

Drug Labeling and Warnings

Biotronix Healthcare by is a Otc medication manufactured, distributed, or labeled by Biotronix Healthcare Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Povidone Iodine 10%

PURPOSE

Purpose
Antiseptic

WARNINGS

Warnings
For external use only. Do not use in the eyes.

STOP USE

Stop use and ask a doctor if Skin shows symptons of irritation, sensitivity, redness, pain or swelling

DOSAGE & ADMINISTRATION

Direction

• Wet hands and forearms with water
• Clean under nails with nail cleaner
• Scrub for 3 minutes with the impregnated brush
• Pay close attention to the nails, cuticles, and interdigital spaces
• Rinse thoroughly with running water
• Repeat

INACTIVE INGREDIENT

Inactive ingredients

Hydroxyethylcellulose, Nonoxynol ethoxylate, Purified Water

INDICATIONS & USAGE

Uses For cleansing hands and arms prior to surgery

OTHER SAFETY INFORMATION

Other information

• Store at room temperature
• Avoid excessive heat above 40 °C (104 °F)
• Protect from freezing
• Latex free

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOTRONIX HEALTHCARE 
povidone iodine sponge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71389-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
NONOXYNOL-10 (UNII: K7O76887AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71389-101-01	20 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	05/03/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	05/03/2018

Labeler - Biotronix Healthcare Industries, Inc. (065762392)