FDA.reportPublic FDA data

Saninta 0.13% BZK Benzalkonium Chloride

Manufacturer
LL Pharma | LL Pharma Inc.
Effective date
2021-03-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:48:37

Label at a glance#

ProductSaninta 0.13% BZK Benzalkonium Chloride
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride, 0.13% v/v

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - STOP USE SECTION

if ithe condition persists or gets worse.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water

Questions or Comments?

OTC - QUESTIONS SECTION

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

Package Label - Principal Display Panel

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

image of 81351-005-03 swabstick labelimage of 81351-005-03 swabstick label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81351-00581351-005-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bf7770de-b71f-32c3-e053-2995a90a643bbe23e545-6c0d-5dfc-e053-2995a90aa3d12021-04-08WarningsExact identifier
spl set id: be23e545-6c0d-5dfc-e053-2995a90aa3d1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.