SaniTyze

Manufacturer
Inopak, Ltd | Crosstex International, Inc.
Effective date
2020-04-03
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 23:37:34

Label at a glance#

ProductSaniTyze Hand Sanitizer
Active ingredientALCOHOL
Label structure20 sections

Indications and uses

To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated use

Dosage and administration

To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated use

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol

Purpose

OTC - PURPOSE SECTION

Antiseptic

Keep away from Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed. Get medical help or contact a Poison Control Center right away. Children should be supervised by an adult when using this product.

Uses

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated use

Warnings

WARNINGS SECTION

Flammable, keep away from heat or flame. For external use only. Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours. Keep out of reach of children. If swallowed. Get medical help or contact a Poison Control Center right away. Children should be supervised by an adult when using this product.

Safety Information

OTHER SAFETY INFORMATION

May discolor certain fabrics and surfaces.

Stop use

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours.

Directions

DOSAGE & ADMINISTRATION SECTION

To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated use

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

SaniTyze 2 oz front

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SaniTyze™

HAND SANITIZER

With

Aloe Vera & Vitamin E

Developed for

Healthcare Professionals

2 fl oz (60 ml)

CROSSTEX

A CANTEL MEDICAL COMPANY

SaniTyze 2 oz frontSaniTyze 2 oz front

SaniTyze 2 oz back

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts

Active Ingredient                             Purpose

Ethyl Alcohol 70% v/v …………….. Antiseptic

Uses: To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated use

Warnings: Flammable, keep away from heat or flame. For external use only. Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours. Keep out of reach of children. If swallowed. Get medical help or contact a Poison Control Center right away. Children should be supervised by an adult when using this product.

Directions: Apply sufficient amount of product to your palm to cover both hands. Rub until dry.

Other Information: May discolor certain fabrics and surfaces.

Inactive Ingredients:

Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

SaniTyze™                           MADE IN                              JWG2-BTL

HAND SANITIZER              USA                                       Rev.3-9/18

REF  JWG2

Bar code

(01)00732224002767

Manufactured for Crosstex International Inc.

Corporate Office 10 Ranch Road Hauppauge NY 11788-4209 USA

Website: www.crosstex.com      E-mail: crosstex@crosstex.com

SaniTyze 2 Oz BackSaniTyze 2 Oz Back

SaniTyze 4 oz front

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SaniTyze™

HAND SANITIZER

With

Aloe Vera & Vitamin E

Developed for

Healthcare Professionals

4 fl oz (118 ml)

CROSSTEX

A CANTEL MEDICAL COMPANY

SaniTyze 4 oz frontSaniTyze 4 oz front

SaniTyze 4 oz back

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts

Active Ingredient                             Purpose

Ethyl Alcohol 70% v/v …………….. Antiseptic

Uses: To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated use

Warnings: Flammable, keep away from heat or flame. For external use only. Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours. Keep out of reach of children. If swallowed. Get medical help or contact a Poison Control Center right away. Children should be supervised by an adult when using this product.

Directions: Apply sufficient amount of product to your palm to cover both hands. Rub until dry.

Other Information: May discolor certain fabrics and surfaces.

Inactive Ingredients:

Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

SaniTyze™                           MADE IN                              JWG-BTL

HAND SANITIZER              USA                                       Rev.3-9/18

REF  JWG

Bar code

(01)00732224002774

MADE IN

USA

Manufactured for Crosstex International Inc.

Corporate Office 10 Ranch Road Hauppauge NY 11788-4209 USA

Website: www.crosstex.com      E-mail: crosstex@crosstex.com

SaniTyze 4 oz BackSaniTyze 4 oz Back

SaniTyze 8 oz front

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SaniTyze™

HAND SANITIZER

With

Aloe Vera & Vitamin E

Developed for

Healthcare Professionals

18 fl oz (532 ml)

CROSSTEX

A CANTEL MEDICAL COMPANY

SaniTyze 8 oz front
SaniTyze 8 oz front

SaniTyze 8 oz back

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts

Active Ingredient                             Purpose

Ethyl Alcohol 70% v/v …………….. Antiseptic

Uses: To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated use

Warnings: Flammable, keep away from heat or flame. For external use only. Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours. Keep out of reach of children. If swallowed. Get medical help or contact a Poison Control Center right away. Children should be supervised by an adult when using this product.

Directions: Apply sufficient amount of product to your palm to cover both hands. Rub until dry.

Other Information: May discolor certain fabrics and surfaces.

Inactive Ingredients:

Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

SaniTyze™                                           REF  JWG


JWG8-BTL                                       HAND SANITIZER

MADE IN JWG8                                 BAR CODE

Rev. 3- 9/18                                      (01) 00732224002743

MADE IN

USA

Manufactured for Crosstex International Inc.

Corporate Office 10 Ranch Road Hauppauge NY 11788-4209 USA

Website: www.crosstex.com      E-mail: crosstex@crosstex.com

SaniTyze 8 oz backSaniTyze 8 oz back

SaniTyze 18 oz front

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SaniTyze™

HAND SANITIZER

With

Aloe Vera & Vitamin E

Developed for

Healthcare Professionals

18 fl oz (532 ml)

CROSSTEX

A CANTEL MEDICAL COMPANY

SaniTyze 18 oz frontSaniTyze 18 oz front

Sanityze  18 oz back

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SaniTyze™

HAND SANITIZER

With

Aloe Vera & Vitamin E

Developed for

Healthcare Professionals

18 fl oz (532 ml)

CROSSTEX

A CANTEL MEDICAL COMPANY

Back 18 oz

Drug Facts

Active Ingredient                             Purpose

Ethyl Alcohol 70% v/v …………….. Antiseptic

Uses: To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated use

Warnings: Flammable, keep away from heat or flame. For external use only. Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours. Keep out of reach of children. If swallowed. Get medical help or contact a Poison Control Center right away. Children should be supervised by an adult when using this product.

Directions: Apply sufficient amount of product to your palm to cover both hands. Rub until dry.

Other Information: May discolor certain fabrics and surfaces.

Inactive Ingredients:

Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

SaniTyze™                                           REF  JWGP

HAND SANITIZER

JWGP-BTL                                        BAR CODE

MADE IN JWG8                                 (01) 00732224002750

Rev. 3- 9/18

MADE IN

USA

Manufactured for Crosstex International Inc.

Corporate Office 10 Ranch Road Hauppauge NY 11788-4209 USA

Website: www.crosstex.com      E-mail: crosstex@crosstex.com

SaniTyze 18 oz backSaniTyze 18 oz back

SaniTyze 28.2 oz. back

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts

Active Ingredient                             Purpose

Ethyl Alcohol 70% v/v …………….. Antiseptic

Uses: To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated use

Warnings: Flammable, keep away from heat or flame. For external use only. Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours. Keep out of reach of children. If swallowed. Get medical help or contact a Poison Control Center right away. Children should be supervised by an adult when using this product.

Directions: Apply sufficient amount of product to your palm to cover both hands. Rub until dry.

Other Information: May discolor certain fabrics and surfaces.

Inactive Ingredients:

Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

SaniTyze™                                           REF  JWGEL

HAND SANITIZER

28.2 fl oz (800ml)                               BAR CODE

MADE IN JWG8                                 (01) 00732224002736

MADE IN

USA

CROSSTEX®

A CANTEL MEDICAL COMPANY

Manufactured for Crosstex International Inc.

Corporate Office 10 Ranch Road Hauppauge NY 11788-4209 USA               JWGEL-PK

Website: www.crosstex.com      E-mail: crosstex@crosstex.com                 Rev. 3- 9/18

SaniTyze 28.2 oz backSaniTyze 28.2 oz back

SaniTyze 33.8 oz back

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts

Active Ingredient                             Purpose

Ethyl Alcohol 70% v/v …………….. Antiseptic

Uses: To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated use

Warnings: Flammable, keep away from heat or flame. For external use only. Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours. Keep out of reach of children. If swallowed. Get medical help or contact a Poison Control Center right away. Children should be supervised by an adult when using this product.

Directions: Apply sufficient amount of product to your palm to cover both hands. Rub until dry.

Other Information: May discolor certain fabrics and surfaces.

Inactive Ingredients:

Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

SaniTyze™                                           REF  JWGEL1

HAND SANITIZER

33.8 fl oz (1000ml)                               BAR CODE

PWGEL1-PK                                        (01) 00732224002729

Rev. 3- 9/18

MADE IN

USA

Manufactured for Crosstex International Inc.

Corporate Office 10 Ranch Road Hauppauge NY 11788-4209 USA

Website: www.crosstex.com      E-mail: crosstex@crosstex.com

CROSSTEX®

A CANTEL MEDICAL COMPANY

SaniTyze 33.8 oz backSaniTyze 33.8 oz back

SaniTyze case lable

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SaniTyze™                           with                                                       JW-CS

HAND SANITIZER              Aloe Vera & Vitamin E                    Rev. 4- 9/18

LOT

80 / 2 Oz. Bottles                             24 / 4 Oz. Bottles                             24 / 8 Oz. Bottles

JWG2                                                    JWG                                                       JWG8

Bar code

         Bar code

         Bar code

 (01)00732224002762                      (01)00732224002779                       (01)00732224002748

16 / 18 Oz. Bottles                           12 / 800ml Pouch                             8 / 1,000 ml Pouch

JWGP                                                    JWGEL                                                  JWGEL1

Bar code

Bar code

Bar code

(01)00732224002755                       (01)00732224002731                       (01)00732224002724

Manufactured for Crosstex International Inc.

Corporate Office 10 Ranch Road Hauppauge NY 11788-4209 USA

Website: www.crosstex.com      E-mail: crosstex@crosstex.com

MADE IN

USA

CROSSTEX®

A CANTEL MEDICAL COMPANY

SaniTyze case labelSaniTyze case label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58575-138-012021-05-17C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-022021-05-17C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-032021-05-17C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-042021-05-17C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-052021-05-17C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-062021-05-17C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-072021-05-17C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-082021-05-17C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-092021-05-17C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-102021-05-17C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-112021-05-17C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-122021-05-17C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-012020-09-27C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-022020-09-27C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-032020-09-27C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-042020-09-27C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-052020-09-27C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-062020-09-27C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-072020-09-27C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-082020-09-27C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-092020-09-27C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-102020-09-27C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-112020-09-27C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-122020-09-27C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-012020-09-25C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-022020-09-25C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-032020-09-25C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-042020-09-25C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-052020-09-25C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-062020-09-25C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-072020-09-25C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-082020-09-25C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-092020-09-25C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-102020-09-25C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-112020-09-25C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-122020-09-25C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-012020-07-22C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-022020-07-22C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-032020-07-22C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-042020-07-22C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-052020-07-22C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-062020-07-22C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-072020-07-22C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-082020-07-22C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-092020-07-22C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-102020-07-22C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-112020-07-22C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138
58575-138-122020-07-22C16284748780-1ab0e2407-2b8d-f274-e053-dbdaa90a6471SaniTyze Hand Sanitizer 138

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
c28d37ef-bab9-cb2c-e053-2a95a90a87d9059fc80f-3062-4041-b2dd-3969e80c7e3a2021-05-17WarningsExact identifier
spl set id: 059fc80f-3062-4041-b2dd-3969e80c7e3a

Reported adverse events (FAERS/openFDA)#

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