TM TITUS MEDICAL POVIDONE IODINE- povidone-iodine ointment

TM Titus Medical Povidone Iodine by

Drug Labeling and Warnings

TM Titus Medical Povidone Iodine by is a Otc medication manufactured, distributed, or labeled by Titus Medical LLC, Lights Medical Manufacture Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Povidone-Iodine USP (10%)

Purpose

Antiseptic

Uses

Antiseptic skin preparation

Warnings

For external use only

Do not use if allergic to iodine in the eyes

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately

ASK DOCTOR

Ask a doctor before use if injuries are deep wounds, puncture wounds or serious burns

Stop use and ask a doctor if infection occurs or if redness, irritation, swelling, or pain persists or increases

Directions

Apply locally as need

Other information

• not made with natural rubber latex
• for hospital or professional use only

Inactive Ingredient

Glycerin, Propylene Glycol, PEG 1450, Sodium Hydrogen Phosphate, Citric Acid, Water

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TM TITUS MEDICAL POVIDONE IODINE 
povidone-iodine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81526-002
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81526-002-01	100 in 1 BOX	06/21/2021
1		1 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	06/21/2021

Labeler - Titus Medical LLC (080306309)

Registrant - Titus Medical LLC (080306309)

Establishment
Name	Address	ID/FEI	Business Operations
Lights Medical Manufacture Co., Ltd.		529128649	manufacture(81526-002)