TM TITUS MEDICAL ANTISEPTIC NON STERILE- povidone-iodine solution

TM TITUS MEDICAL ANTISEPTIC Non Sterile by

Drug Labeling and Warnings

TM TITUS MEDICAL ANTISEPTIC Non Sterile 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

Use:

Antiseptic skin preparation

WARNINGS

Warnings:

Do not use if allergic to iodine in eyes

For external use only

Avoid "pooling" beneath patients. 

Avoid excessive heat. Store at room temperature.

ASK DOCTOR

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

Stop use and ask a doctor if

• redness, irritation, swelling, or pain persists or increases
• infection occurs

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

DOSAGE & ADMINISTRATION

Apply locally as need

OTHER SAFETY INFORMATION

Other information

• 1% titratable iodine
• not made with natural rubber latex
• for hospital or professional use only

Inactive Ingredient

Citric acid, Disodium phosphate, Nonoxynol-9, Sodium hydroxide, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TM TITUS MEDICAL ANTISEPTIC NON STERILE 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81526-001
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 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81526-001-01	30 mL in 1 POUCH; Type 0: Not a Combination Product	02/04/2021
2	NDC: 81526-001-02	200 in 1 BOX	02/04/2021
2		30 mL 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	02/04/2021

Labeler - Titus Medical LLC (080306309)

Registrant - Titus Medical LLC (080306309)

Establishment
Name	Address	ID/FEI	Business Operations
Lights Medical Manufacture Co., Ltd.		529128649	manufacture(81526-001)