OTC Medication Information: BZK Alcohol Free Hand Sanitizer

BZK ALCOHOL FREE HAND SANITIZER- benzalkonium chloride liquid
Sarati International, Inc.

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.

Drug Facts

Active Ingredient:
Benzalkonium Chloride 0.13%

Purpose:
Hand & Skin Sanitizer

Uses: BZK™ Alcohol Free Hand Sanitizer provides revolutionary
protection in an alcohol-free formula. The scientifically-proven
solution kills harmful germs, bacteria, and microbes, and gently
soothes and softens skin with aloe vera. Recommended for
repeated use.

Warnings: Do not freeze + For external use only + Do not use in
ears, eyes or mouth + When using this product, avoid contact
with the eyes + In case of contact, flush eyes with water + Stop
use and ask a doctor if redness or irritation develops and persists
for more than 72 hours

+ Keep out of reach of children + Children
should be supervised when using this product.

Directions: Apply liberally to the palms of the hands or areas of
damaged skin. Rub into skin until dry. Recommended for
repeated use.

Other Information: Store in a cool dry place below 104°F(40°C).

Inactive Ingredients: Aloe Barbadensis leaf extract, Aqua,
Citric Acid, Caprylyl Glucoside, Laureth-4, Polyhexanide,
Phenoxyethanol, Triethoxysilylpropyl Steardimonium Chloride.

Questions? 1-800-920-7650 Mon-Fri 10AM-4PM (EST)

Product Label

BZK™

Alcohol Free
Hand Sanitizer

UP TO 4 HOURS OF PROTECTION + Kills
up to 99.9% of Harmful Germs and
Bacteria + Naturally Derived, Alcohol and
Bleach Free + Gentle and Non-stinging
with Aloe Vera

1.7 FL OZ (50 ML)

MADE IN THE USA

BZK™ products are manufactured under
strict quality guidelines under 21 CFR at
a cGMP FDA-registered site.

Distributed By BZK HealthBuffalo NY, 14221

bzkhealth.com

1.7 FL OZ

BZK 50mL
(click image for full-size original)

2 FL OZ

BZK 59mL
(click image for full-size original)

rres

BZK ALCOHOL FREE HAND SANITIZER benzalkonium chloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67676-006
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
WATER
CITRIC ACID MONOHYDRATE
CAPRYLYL GLUCOSIDE
LAURETH-4
POLIHEXANIDE
PHENOXYETHANOL
TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67676-006-01 50 mL in 1 BOTTLE, SPRAY None
2 NDC:67676-006-02 59 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/31/2021
Labeler — Sarati International, Inc. (160219770)
Registrant — Sarati International, Inc. (160219770)
Establishment
Name Address ID/FEI Operations
Sarati International, Inc. 160219770 repack (67676-006), repack (67676-006)

Revised: 03/2021 Sarati International, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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