Hand Sanitizer

Manufacturer
Nanoolflon de México, S.A. de C.V.
Effective date
2020-05-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:00

Key Label Information#

Active Ingredients And Purpose

Active Ingredient(s)

Alcohol 80% 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

GLYCERIN, HYDROXYETHYL CELLULOSE, N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18), BENZYLDIDECYLMETHYLAMMONIUM CHLORIDE, PURIFIED WATER USP.

Package Label - Principal Display Panel

236 mL NDC: 78262-001-01 500 mL NDC: 78262-001-02

Label Images#

236 mL 80
236 mL 80
500 mL 80
500 mL 80

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN1
1041498ethanol 0.8 ML/ML Topical GelSCD1
1041498ethanol 80 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78262-001-012021-07-23C16284748780-1c7ccaba7-2223-fd44-e053-dadaa90aa01ba6a4c91b-e32f-2f28-e053-2995a90a3e39
78262-001-022021-07-23C16284748780-1c7ccaba7-2223-fd44-e053-dadaa90aa01ba6a4c91b-e32f-2f28-e053-2995a90a3e39

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78262-001-01Hand Sanitizer236 mL in 1 BOTTLEGEL2361
78262-001-02Hand Sanitizer500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78262-001HAND SANITIZER (ALCOHOL) GEL [NANOOLFLON DE MÉXICO, S.A. DE C.V.]1Legacy NDC, 2 package rows20200528_a6a4c91b-e32f-2f28-e053-2995a90a3e39.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78262-00178262-001-01, 78262-001-02

Ingredients#

Complete SPL Sections#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 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

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

GLYCERIN, HYDROXYETHYL CELLULOSE, N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18), BENZYLDIDECYLMETHYLAMMONIUM CHLORIDE, PURIFIED WATER USP.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236 mL NDC: 78262-001-01 500 mL NDC: 78262-001-02

Source Document#

Source XML