SANINTA 10% POVIDONE-IODINE- povidone-iodine solution liquid

Saninta 10% Povidone-Iodine by

Drug Labeling and Warnings

Saninta 10% Povidone-Iodine by is a Otc medication manufactured, distributed, or labeled by Lernapharm. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Povidone-Iodine 10% w/v

Purpose

Antiseptic

Use

Antiseptic skin preparation. Helps reduce bacteria that potentially can cause skin infection.

Warnings

For external use only.

Do not use

Do not use

• if allergic to iodine
• in the eyes

Stop use and ask a doctor

Stop use and ask a doctorif

• injuries are deep puncture wounds or serious burns
• redness, irritation, swelling or pain persists or increases
• infection occurs

Avoid pooling beneath patient

Avoid pooling beneath patient

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.

Directions

• Clean the area.
• apply locally as needed

Other Information

• 1% titratable iodine
• not made with natural rubber latex
• for hospital or professional use only
• Store at room temperature between 59-86ºF (15 - 30ºC).
• Avoid freezing and excessive heat above 40ºC (104ºF).

Inactive ingredients

Citric Acid, Glycerol, Nonoxynol-9, Purified Water USP, Sodium Hydroxide, Sodium Phosphate Dibasic

Questions or Comments?

Questions or Comments? Tel.: 1-866-322-4634, weekdays between 8:00 am and 4:00 pm EST

Package Label - Principal Display Panel

NDC: 68356-601-01 / 68356-601-601-02 / 68356-601-03

Product # 601-01 / 601-02 / 601-03

Hold upright

[Tear here and pour]

[Three 4-inch antiseptic swabsticks impregnated with 10% W/V povidone-iodine solution]

[Tear open]

Saninta

Antiseptic Solution

10% w/v Povidone-Iodine Solution

10% Povidone-Iodine

[0.75 Fl. oz (22.5 mL)]

[0.5 Fl. oz (15 mL)]

Do Not Reuse

multiple-use cross-through logo

UPC Code

Manufactured by:

Lernapharm (LORIS) Inc.

2323 HALPERN, MONTREAL

QUEBEC, CANADA H4S 1S3

Made in Canada

LOT #: XXXX

EXP.: MM/YYYY

INGREDIENTS AND APPEARANCE

SANINTA 10% POVIDONE-IODINE 
povidone-iodine solution liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68356-601
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)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68356-601-01	3 in 1 POUCH	02/26/2024
1		2.3 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 68356-601-02	22.5 mL in 1 PACKET; Type 0: Not a Combination Product	02/26/2024
3	NDC: 68356-601-03	15 mL in 1 PACKET; Type 0: Not a Combination Product	11/14/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	02/26/2024

Labeler - Lernapharm (206940905)

Registrant - Lernapharm (206940905)

Establishment
Name	Address	ID/FEI	Business Operations
Lernapharm		206940905	manufacture(68356-601) , analysis(68356-601) , label(68356-601) , pack(68356-601)