Sanitize 75

Manufacturer
CRI Tolling
Effective date
2020-09-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:26:38

Label at a glance#

ProductSanitize NT-75
Active ingredientISOPROPYL ALCOHOL, ALCOHOL
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

Sanitize 80

a. Ethanol (80%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
b. Glycerol (0.725% v/v).
c. Copolymer (6 % v/v).
d. Trolamine (0.3 % v/v).
e. FD&C Blue No.1 (0.00018 % v/v).
f. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Sanitize NT-80

a. Ethanol (80%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
b. Glycerol (0.725% v/v).
c. Hydroxyethyl Cellulose (1.8 % v/v).

d. Trolamine (0.3 v/v).

e. FD&C Blue No.1 (0.00018 % v/v).
e. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Sanitize 75

a. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

b. Glycerol (0.725 % v/v).
c. Copolymer (8.2 % v/v).
d. Trolamine (1 % v/v)
e. FD&C Blue No.1 (0.00018 % v/v).
f. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Sanitize NT-75

a. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
b. Glycerol (0.725% v/v).
c. Hydroxyethyl Cellulose (1.8 % v/v).

d. Trolamine (0.3 v/v).

e. FD&C Blue No.1 (0.00018 % v/v).
e. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Sanitize 75 (NDC# 76748-0275 and Sanitize NT-75 (NDC# 76748-0475)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Sanitize 80 (NDS# 76748-0180) and Sanitize NT-80 (NDC# 76748-0380)

Ethanol 80% v/v. Purpose Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SANITIZE 80 76748-0180-1SANITIZE 80 76748-0180-1SANITIZE 80 76748-0180-2SANITIZE 80 76748-0180-2SANITIZE 80 76748-0180-3SANITIZE 80 76748-0180-3SANITIZE NT-80 76748-0380-1SANITIZE NT-80 76748-0380-1SANITIZE NT-80 76748-0380-2SANITIZE NT-80 76748-0380-2SANITIZE NT-80 76748-0380-3SANITIZE NT-80 76748-0380-3SANITIZE 75 76748-0275-1SANITIZE 75 76748-0275-1SANITIZE 75 76748-0275-2SANITIZE 75 76748-0275-2SANITIZE 75 76748-0275-3SANITIZE 75 76748-0275-3SANITIZE NT 75 76748-0475-1SANITIZE NT 75 76748-0475-1SANITIZE NT 75 76748-0475-2SANITIZE NT 75 76748-0475-2SANITIZE NT 75 76748-0475-3SANITIZE NT 75 76748-0475-3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76748-0180-12022-01-28C16284748780-1d6a99b39-79c8-a426-e053-dadaa90af4c2CRI Tolling - Sanitize 75 (IPA 75) in drum (1), IBC (2), and pail (3)
76748-0180-22022-01-28C16284748780-1d6a99b39-79c8-a426-e053-dadaa90af4c2CRI Tolling - Sanitize 75 (IPA 75) in drum (1), IBC (2), and pail (3)
76748-0180-32022-01-28C16284748780-1d6a99b39-79c8-a426-e053-dadaa90af4c2CRI Tolling - Sanitize 75 (IPA 75) in drum (1), IBC (2), and pail (3)
76748-0275-12022-01-28C16284748780-1d6a99b39-79c8-a426-e053-dadaa90af4c2CRI Tolling - Sanitize 75 (IPA 75) in drum (1), IBC (2), and pail (3)
76748-0275-22022-01-28C16284748780-1d6a99b39-79c8-a426-e053-dadaa90af4c2CRI Tolling - Sanitize 75 (IPA 75) in drum (1), IBC (2), and pail (3)
76748-0275-32022-01-28C16284748780-1d6a99b39-79c8-a426-e053-dadaa90af4c2CRI Tolling - Sanitize 75 (IPA 75) in drum (1), IBC (2), and pail (3)
76748-0380-12022-01-28C16284748780-1d6a99b39-79c8-a426-e053-dadaa90af4c2CRI Tolling - Sanitize 75 (IPA 75) in drum (1), IBC (2), and pail (3)
76748-0380-22022-01-28C16284748780-1d6a99b39-79c8-a426-e053-dadaa90af4c2CRI Tolling - Sanitize 75 (IPA 75) in drum (1), IBC (2), and pail (3)
76748-0380-32022-01-28C16284748780-1d6a99b39-79c8-a426-e053-dadaa90af4c2CRI Tolling - Sanitize 75 (IPA 75) in drum (1), IBC (2), and pail (3)
76748-0475-12022-01-28C16284748780-1d6a99b39-79c8-a426-e053-dadaa90af4c2CRI Tolling - Sanitize 75 (IPA 75) in drum (1), IBC (2), and pail (3)
76748-0475-22022-01-28C16284748780-1d6a99b39-79c8-a426-e053-dadaa90af4c2CRI Tolling - Sanitize 75 (IPA 75) in drum (1), IBC (2), and pail (3)
76748-0475-32022-01-28C16284748780-1d6a99b39-79c8-a426-e053-dadaa90af4c2CRI Tolling - Sanitize 75 (IPA 75) in drum (1), IBC (2), and pail (3)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76748-0180-1Sanitize 80204412 mL in 1 DRUMGEL2044122
76748-0180-2Sanitize 801022000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL10220002
76748-0180-3Sanitize 8018921 mL in 1 PAILGEL189212
76748-0275-1Sanitize 75204412 mL in 1 DRUMGEL2044122
76748-0275-2Sanitize 751022000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL10220002
76748-0275-3Sanitize 7518921 mL in 1 PAILGEL189212
76748-0380-1Sanitize NT-80204412 mL in 1 DRUMGEL2044122
76748-0380-2Sanitize NT-801022000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL10220002
76748-0380-3Sanitize NT-8018921 mL in 1 PAILGEL189212
76748-0475-1Sanitize NT-75204412 mL in 1 DRUMGEL2044122
76748-0475-2Sanitize NT-751022000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL10220002
76748-0475-3Sanitize NT-7518921 mL in 1 PAILGEL189212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76748-0180SANITIZE NT-75 (HAND SANITIZER) GEL SANITIZE 80 (HAND SANITIZER) GEL SANITIZE NT-80 (HAND SANITIZER) GEL SANITIZE 75 (HAND SANITIZER) GEL [CRI TOLLING]2Legacy NDC, 3 package rows20200903_a61a7a37-7743-9376-e053-2a95a90aeb3e.zip
76748-0275SANITIZE NT-75 (HAND SANITIZER) GEL SANITIZE 80 (HAND SANITIZER) GEL SANITIZE NT-80 (HAND SANITIZER) GEL SANITIZE 75 (HAND SANITIZER) GEL [CRI TOLLING]2Legacy NDC, 3 package rows20200903_a61a7a37-7743-9376-e053-2a95a90aeb3e.zip
76748-0380SANITIZE NT-75 (HAND SANITIZER) GEL SANITIZE 80 (HAND SANITIZER) GEL SANITIZE NT-80 (HAND SANITIZER) GEL SANITIZE 75 (HAND SANITIZER) GEL [CRI TOLLING]2Legacy NDC, 3 package rows20200903_a61a7a37-7743-9376-e053-2a95a90aeb3e.zip
76748-0475SANITIZE NT-75 (HAND SANITIZER) GEL SANITIZE 80 (HAND SANITIZER) GEL SANITIZE NT-80 (HAND SANITIZER) GEL SANITIZE 75 (HAND SANITIZER) GEL [CRI TOLLING]2Legacy NDC, 3 package rows20200903_a61a7a37-7743-9376-e053-2a95a90aeb3e.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 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
ae5a138a-bcb1-08dd-e053-2a95a90a0478a61a7a37-7743-9376-e053-2a95a90aeb3e2020-09-02WarningsExact identifier
spl id: ae5a138a-bcb1-08dd-e053-2a95a90a0478
spl set id: a61a7a37-7743-9376-e053-2a95a90aeb3e

Reported adverse events (FAERS/openFDA)#

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