Hand Sanitizer

Manufacturer
H&F TECH INTERNATIONAL, S.A. DE C.V.
Effective date
2020-06-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:19:04

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure14 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping. 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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin. 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

  • Wet hands thoroughly with product and allow to dry without wiping.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Fragrance, Hydroxyethylcellulose, Purified Water USP

Other information

STORAGE AND HANDLING SECTION

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

473473

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

473mL

473473

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

960mL 960ml960ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77552-005-01Hand Sanitizer473 mL in 1 BOTTLEGEL4732
77552-005-02Hand Sanitizer960 mL in 1 BOTTLEGEL9602
77552-005-03Hand Sanitizer3785.41 mL in 1 BOTTLEGEL3785.412

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77552-005HAND SANITIZER (ETHYL ALCOHOL) GEL [H&F TECH INTERNATIONAL, S.A. DE C.V.]2Legacy NDC, 3 package rows20200626_a70b6c88-846a-cee3-e053-2a95a90ac722.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77552-00577552-005-01, 77552-005-03, 77552-005-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
a8efa851-e1e2-6739-e053-2a95a90a1d6ba70b6c88-846a-cee3-e053-2a95a90ac7222020-06-25WarningsExact identifier
spl id: a8efa851-e1e2-6739-e053-2a95a90a1d6b
spl set id: a70b6c88-846a-cee3-e053-2a95a90ac722

Reported adverse events (FAERS/openFDA)#

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