Drug Facts - Saninta 0.13% BZK Benzalkonium Chloride

Saninta 0.13% BZK Benzalkonium Chloride by

Drug Labeling and Warnings

Saninta 0.13% BZK Benzalkonium Chloride by is a Otc medication manufactured, distributed, or labeled by LL Pharma, LL Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANINTA 0.13% BZK BENZALKONIUM CHLORIDE- benzalkonium chloride liquid 
LL Pharma

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts - Saninta 0.13% BZK Benzalkonium Chloride

Active Ingredient

Benzalkonium chloride, 0.13% v/v

Purpose

First Aid Antiseptic

Use

First aid to help reduce the risk of infection in minor cuts, scrapes, and burns.

Warnings

For external use only. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Do not use

• In the eyes or apply over large areas of the body.
• For longer than 1 week unless directed by a doctor.

Stop use and ask a doctor

if ithe condition persists or gets worse.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Tear open pouch and use as part of your daily cleansing routine.
• Clean the affected area.
• Apply this product on the area 1 to 3 times daily.
• May be covered with a sterile bandage.
• If bandaged, let dry first.

Other Information

• Store at room temperature between 59-86ºF (15-30°C)

Inactive ingredients

Purified water

Questions or Comments?

Call 1-833-336-6159, weekdays between 8:00 am and 6:00 pm EST

Package Label - Principal Display Panel

NDC: 81351-005-003

Product: 005-03

Saninta

0.13% BZK

Benzalkonium Chloride

For external use only

Hold upright

TEAR OPEN

Three 4-inch swabsticks impregnated with 0.13% v/v benzalkonium chloride antiseptic solution

For hospital and professional use only

No latex logo

Manufactured by:

LL Pharma Inc.

5789 rue Cypihot, Saint-Laurent (Montreal), Quebec H4S 1R3

Made in Canada

LOT #:

EXP.:

UPC Code

SANINTA 0.13% BZK BENZALKONIUM CHLORIDE 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81351-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81351-005-03	3 in 1 POUCH	03/22/2021
1		2.3 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/22/2021	04/08/2021

Labeler - LL Pharma (206925146)

Registrant - LL Pharma (206925146)

Establishment
Name	Address	ID/FEI	Business Operations
LL Pharma Inc.		206925146	manufacture(81351-005) , analysis(81351-005) , label(81351-005) , pack(81351-005) , relabel(81351-005) , repack(81351-005)

Revised: 4/2021

Document Id: bf7770de-b71f-32c3-e053-2995a90a643b

34390-5

Set id: be23e545-6c0d-5dfc-e053-2995a90aa3d1

Version: 2

Effective Time: 20210408