Hand Sanitizer

Manufacturer
Saniklyn, S. de R.L. de M.I.
Effective date
2020-07-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:22:21

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 USP, glycerine, triethalonamine and carbomer.

Package Label - Principal Display Panel

60 mL NDC: 79004-003-01 473 mL NDC: 79004-003-02 1000 mL NDC: 79004-003-03 3785 mL NDC: 79004-003-04

Label Images#

PDP 60ml
PDP 60ml
PDP 473 ml
PDP 473 ml
PDP 1000 mL
PDP 1000 mL
PDP 3785 mL
PDP 3785 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2277550ethanol 72 % Topical GelPSN2
2277550ethanol 0.72 ML/ML Topical GelSCD2
2277550ethanol 72 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79004-004-02Teem Hogar473 mL in 1 BOTTLEGEL4732
79004-004-03Teem Hogar60 mL in 1 BOTTLEGEL602
79004-004-04Teem Hogar1000 mL in 1 BOTTLEGEL10002
79004-004-05Teem Hogar3785 mL in 1 BOTTLEGEL37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79004-004TEEM HOGAR (ALCOHOL) GEL [SANIKLYN, S. DE R.L. DE M.I.]2Legacy NDC, 4 package rows20200724_a9d14aa0-e499-322b-e053-2995a90af220.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79004-00479004-004-03, 79004-004-02, 79004-004-04, 79004-004-05

Ingredients#

Complete SPL Sections#

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 USP, glycerine, triethalonamine and carbomer.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 mL NDC: 79004-003-01 473 mL NDC: 79004-003-02 1000 mL NDC: 79004-003-03 3785 mL NDC: 79004-003-04

Source Document#

Source XML