SANZIDERM Antiseptic Hand Sanitizer 8OZ

Manufacturer
Beauty Partners LLC | Nu-World Corporation
Effective date
2020-06-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:26

Key Label Information#

Active Ingredients And Purpose

Active Ingredient(s)

Alcohol 72% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Uses

Use

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

Warnings

Warnings

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

Do not use

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

Directions And Dosage

Directions

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 Label Information

Other information

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

Inactive ingredients

Water, Carbomer, Aminomethyl Propanol,Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Ethyl Hexanediol, Phenoxyethanol

Package Label - Principal Display Panel-SANXIDERM Anti-bacterial Hand Gel

236mL NDC: 78229-001-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-SANZIDERM Antiseptic Hand Sanitizer 8OZ

236ML NDC:78229-002-00

Label Images#

METRO WAGS UK 4-13
METRO WAGS UK 4-13
PRECISION 8 OZ SanziDermSanitizer (004)
PRECISION 8 OZ SanziDermSanitizer (004)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2277550ethanol 72 % Topical GelPSN1
2277550ethanol 0.72 ML/ML Topical GelSCD1
2277550ethanol 72 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78229-001-002023-07-28C16284748780-10191ceaa-6dc7-198a-e063-dbdaa90aec3ea75aadcf-eae2-4c72-e053-2995a90ab343
78229-002-002023-07-28C16284748780-10191ceaa-6dc7-198a-e063-dbdaa90aec3ea75aadcf-eae2-4c72-e053-2995a90ab343

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78229-001-00SANXIDERM Anti-bacterial Hand Gel 8OZ236 mL in 1 BOTTLEGEL2361
78229-002-00SANZIDERM Antiseptic Hand Sanitizer 8OZ236 mL in 1 BOTTLEGEL2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78229-001SANXIDERM ANTI-BACTERIAL HAND GEL 8OZ (ALCOHOL) GEL SANZIDERM ANTISEPTIC HAND SANITIZER 8OZ (ALCOHOL) GEL [BEAUTY PARTNERS LLC]1Legacy NDC, 1 package rows20200608_a75aadcf-eae2-4c72-e053-2995a90ab343.zip
78229-002SANXIDERM ANTI-BACTERIAL HAND GEL 8OZ (ALCOHOL) GEL SANZIDERM ANTISEPTIC HAND SANITIZER 8OZ (ALCOHOL) GEL [BEAUTY PARTNERS LLC]1Legacy NDC, 1 package rows20200608_a75aadcf-eae2-4c72-e053-2995a90ab343.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78229-00178229-001-00
78229-00278229-002-00

Ingredients#

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

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: Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol (1.45% v/v). Hydrogen peroxide (0.125% v/v). 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

Alcohol 72% 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

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

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

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

Water, Carbomer, Aminomethyl Propanol,Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Ethyl Hexanediol, Phenoxyethanol

Package Label - Principal Display Panel-SANXIDERM Anti-bacterial Hand Gel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236mL NDC: 78229-001-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-SANZIDERM Antiseptic Hand Sanitizer 8OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236ML NDC:78229-002-00

Source Document#

Source XML