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

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

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

Product # 601-01 / 601-02

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)]

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

image of NDC 68356-601-01 label

image of NDC 68356-601-02 label

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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

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

Labeler - Lernapharm (206940905)

Registrant - Lernapharm (206940905)

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

Drug Facts - Saninta 10% w/v Povidone-Iodine Solution