NDC 58575-138 Sanityze Hand Sanitizer

NDC Product Code 58575-138

NDC 58575-138-01

Package Description: 60 mL in 1 BOTTLE

NDC 58575-138-02

Package Description: 118 mL in 1 BOTTLE

NDC 58575-138-03

Package Description: 237 mL in 1 BOTTLE

NDC 58575-138-04

Package Description: 532 mL in 1 BOTTLE

NDC 58575-138-05

Package Description: 800 mL in 1 POUCH

NDC 58575-138-06

Package Description: 1000 mL in 1 POUCH

NDC 58575-138-07

Package Description: 4800 mL in 1 CASE

NDC 58575-138-08

Package Description: 2832 mL in 1 CASE

NDC 58575-138-09

Package Description: 5688 mL in 1 CASE

NDC 58575-138-10

Package Description: 8512 mL in 1 CASE

NDC 58575-138-11

Package Description: 9600 mL in 1 CASE

NDC 58575-138-12

Package Description: 8000 mL in 1 CASE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Sanityze Hand Sanitizer with NDC 58575-138 is a product labeled by Inopak, Ltd. The generic name of Sanityze Hand Sanitizer is . The product's dosage form is and is administered via form.

Labeler Name: Inopak, Ltd

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Inopak, Ltd
Labeler Code: 58575
Start Marketing Date: 01-01-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Sanityze Hand Sanitizer Product Label Images

Sanityze Hand Sanitizer Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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

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

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 SANITIZERWithAloe Vera & Vitamin EDeveloped forHealthcare Professionals2 fl oz (60 ml)CROSSTEXA CANTEL MEDICAL COMPANY

Sanityze 2 Oz Back

Drug FactsActive Ingredient                             PurposeEthyl Alcohol 70% v/v …………….. AntisepticUses: To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated useWarnings: 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, WaterSaniTyze™                           MADE IN                              JWG2-BTLHAND SANITIZER              USA                                       Rev.3-9/18REF  JWG2Bar code(01)00732224002767Manufactured for Crosstex International Inc.Corporate Office 10 Ranch Road Hauppauge NY 11788-4209 USAWebsite: www.crosstex.com      E-mail: crosstex@crosstex.com

Sanityze 4 Oz Front

SaniTyze™HAND SANITIZERWithAloe Vera & Vitamin EDeveloped forHealthcare Professionals4 fl oz (118 ml)CROSSTEXA CANTEL MEDICAL COMPANY

Sanityze 4 Oz Back

Drug FactsActive Ingredient                             PurposeEthyl Alcohol 70% v/v …………….. AntisepticUses: To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated useWarnings: 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, WaterSaniTyze™                           MADE IN                              JWG-BTLHAND SANITIZER              USA                                       Rev.3-9/18REF  JWGBar code(01)00732224002774MADE INUSAManufactured for Crosstex International Inc.Corporate Office 10 Ranch Road Hauppauge NY 11788-4209 USAWebsite: www.crosstex.com      E-mail: crosstex@crosstex.com

Sanityze 8 Oz Front

SaniTyze™HAND SANITIZERWithAloe Vera & Vitamin EDeveloped forHealthcare Professionals18 fl oz (532 ml)CROSSTEXA CANTEL MEDICAL COMPANY

Sanityze 8 Oz Back

Drug FactsActive Ingredient                             PurposeEthyl Alcohol 70% v/v …………….. AntisepticUses: To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated useWarnings: 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, WaterSaniTyze™                                           REF  JWGJWG8-BTL                                       HAND SANITIZERMADE IN JWG8                                 BAR CODERev. 3- 9/18                                      (01) 00732224002743MADE INUSAManufactured for Crosstex International Inc.Corporate Office 10 Ranch Road Hauppauge NY 11788-4209 USAWebsite: www.crosstex.com      E-mail: crosstex@crosstex.com

Sanityze 18 Oz Front

SaniTyze™HAND SANITIZERWithAloe Vera & Vitamin EDeveloped forHealthcare Professionals18 fl oz (532 ml)CROSSTEXA CANTEL MEDICAL COMPANY

Sanityze  18 Oz Back

SaniTyze™HAND SANITIZERWithAloe Vera & Vitamin EDeveloped forHealthcare Professionals18 fl oz (532 ml)CROSSTEXA CANTEL MEDICAL COMPANYBack 18 ozDrug FactsActive Ingredient                             PurposeEthyl Alcohol 70% v/v …………….. AntisepticUses: To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated useWarnings: 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, WaterSaniTyze™                                           REF  JWGPHAND SANITIZERJWGP-BTL                                        BAR CODEMADE IN JWG8                                 (01) 00732224002750Rev. 3- 9/18MADE INUSAManufactured for Crosstex International Inc.Corporate Office 10 Ranch Road Hauppauge NY 11788-4209 USAWebsite: www.crosstex.com      E-mail: crosstex@crosstex.com

Sanityze 28.2 Oz. Back

Drug FactsActive Ingredient                             PurposeEthyl Alcohol 70% v/v …………….. AntisepticUses: To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated useWarnings: 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, WaterSaniTyze™                                           REF  JWGELHAND SANITIZER28.2 fl oz (800ml)                               BAR CODEMADE IN JWG8                                 (01) 00732224002736MADE INUSACROSSTEX®A CANTEL MEDICAL COMPANYManufactured for Crosstex International Inc.Corporate Office 10 Ranch Road Hauppauge NY 11788-4209 USA               JWGEL-PKWebsite: www.crosstex.com      E-mail: crosstex@crosstex.com                 Rev. 3- 9/18

Sanityze 33.8 Oz Back

Drug FactsActive Ingredient                             PurposeEthyl Alcohol 70% v/v …………….. AntisepticUses: To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated useWarnings: 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, WaterSaniTyze™                                           REF  JWGEL1HAND SANITIZER33.8 fl oz (1000ml)                               BAR CODEPWGEL1-PK                                        (01) 00732224002729Rev. 3- 9/18MADE INUSAManufactured for Crosstex International Inc.Corporate Office 10 Ranch Road Hauppauge NY 11788-4209 USAWebsite: www.crosstex.com      E-mail: crosstex@crosstex.comCROSSTEX®A CANTEL MEDICAL COMPANY

Sanityze Case Lable

SaniTyze™                           with                                                       JW-CSHAND SANITIZER              Aloe Vera & Vitamin E                    Rev. 4- 9/18LOT80 / 2 Oz. Bottles                             24 / 4 Oz. Bottles                             24 / 8 Oz. BottlesJWG2                                                    JWG                                                       JWG8Bar code         Bar code         Bar code (01)00732224002762                      (01)00732224002779                       (01)0073222400274816 / 18 Oz. Bottles                           12 / 800ml Pouch                             8 / 1,000 ml PouchJWGP                                                    JWGEL                                                  JWGEL1Bar codeBar codeBar code(01)00732224002755                       (01)00732224002731                       (01)00732224002724Manufactured for Crosstex International Inc.Corporate Office 10 Ranch Road Hauppauge NY 11788-4209 USAWebsite: www.crosstex.com      E-mail: crosstex@crosstex.comMADE INUSACROSSTEX®A CANTEL MEDICAL COMPANY

* Please review the disclaimer below.