Crosstex SaniTyze Hand Sanitizer

SaniTyze by

Drug Labeling and Warnings

SaniTyze by is a Otc medication manufactured, distributed, or labeled by Crosstex International Inc., Inopak, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANITYZE- hand sanitizer gel 
Crosstex 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.

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Crosstex SaniTyze Hand Sanitizer

Active Ingredient

Alcohol

Purpose

Antiseptic

Keep away from Children 

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

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.

Safety Information

May discolor certain fabrics and surfaces.

Stop Use

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

Directions

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

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 2 oz

Front

SaniTyze™

HAND SANITIZER

With

Aloe Vera & Vitamin E

Developed for

Healthcare Professionals

2 fl oz (60 ml)

CROSSTEX

A CANTEL MEDICAL COMPANY

Back

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 4 oz

Font

SaniTyze™

HAND SANITIZER

With

Aloe Vera & Vitamin E

Developed for

Healthcare Professionals

4 fl oz (118 ml)

CROSSTEX

A CANTEL MEDICAL COMPANY

Back

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 8 oz

Front

SaniTyze™

HAND SANITIZER

With

Aloe Vera & Vitamin E

Developed for

Healthcare Professionals

8 fl oz (237 ml)

CROSSTEX

A CANTEL MEDICAL COMPANY

Back label

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

Bar code

HAND SANITIZER

JWG8-BTL                              

MADE IN JWG8                                 (01) 00732224002743

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

Front

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 28.2 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  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 33.8 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  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 Case label

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 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24794-138
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	21 mL  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
PERFLUOROALKYLETHYL ACRYLATES (C6-C14) (UNII: TKA54G588X)
ALOE (UNII: V5VD430YW9)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24794-138-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019	02/02/2020
2	NDC: 24794-138-02	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019	02/02/2020
3	NDC: 24794-138-03	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019	02/02/2020
4	NDC: 24794-138-04	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019	02/02/2020
5	NDC: 24794-138-05	800 mL in 1 POUCH; Type 0: Not a Combination Product	01/01/2019	02/02/2020
6	NDC: 24794-138-06	1000 mL in 1 POUCH; Type 0: Not a Combination Product	01/01/2019	02/02/2020
7	NDC: 24794-138-07	4800 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2019	02/02/2020
8	NDC: 24794-138-08	2832 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2019	02/02/2020
9	NDC: 24794-138-09	5688 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2019	02/02/2020
10	NDC: 24794-138-10	8512 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2019	02/02/2020
11	NDC: 24794-138-11	9600 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2019	02/02/2020
12	NDC: 24794-138-12	8000 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2019	02/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/01/2019	02/02/2020

Labeler - Crosstex International Inc. (057728685)

Establishment
Name	Address	ID/FEI	Business Operations
Crosstex International Inc.		057728685	label(24794-138)

Revised: 2/2020

Document Id: 5e247e85-7554-4b32-95b1-81e0c48a30a6

34390-5

Set id: a7ce8018-21c5-4cdb-8006-2da0d82e842d

Version: 4

Effective Time: 20200202

 

Crosstex International Inc.