FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
NATURATLALI S DE RL DE CV
Effective date
2020-11-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:33:20

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% 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

Flammable, keep away from fire or flame.

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on open 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

Purified water USP, glycerin, carbomer, triethaanolamine, methylparabene, propylparabene, propylene glycol, DMDM Hydantoin.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

946 mL NDC: 77143-004-08 Kathari 946 mlKathari 946 ml

250 mL NDC: 77143-004-01 Etiqueta 250 mLEtiqueta 250 mL

236 mL NDC: 77143-004-02

236 mL236 mL

3785 mL NDC: 77143-004-06

3785 mL3785 mL

500 mL NDC: 77143-004-03

500 mL500 mL

946 mL NDC: 77143-004-05

946 mL946 mL

250mL NDC: 77143-004-10

250 mL250 mL

3785 mL NDC: 77143-004-11

3785 mL3785 mL

60 mL NDC: 77143-004-12

60 mL front60 mL front

60 mL back60 mL back

125 mL NDC: 77143-004-18

pdp 125 ml vituspdp 125 ml vitus

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN7
581662ethanol 0.7 ML/ML Topical GelSCD7
581662ethanol 70 % Topical GelSY7
581662ethyl alcohol 70 % Topical GelSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77143-004-012023-01-30C16284748780-1f386c64a-33fd-0266-e053-dadaa90a7c1a77143-004 - 70% alcohol
77143-004-022023-01-30C16284748780-1f386c64a-33fd-0266-e053-dadaa90a7c1a77143-004 - 70% alcohol
77143-004-032023-01-30C16284748780-1f386c64a-33fd-0266-e053-dadaa90a7c1a77143-004 - 70% alcohol
77143-004-052023-01-30C16284748780-1f386c64a-33fd-0266-e053-dadaa90a7c1a77143-004 - 70% alcohol
77143-004-062023-01-30C16284748780-1f386c64a-33fd-0266-e053-dadaa90a7c1a77143-004 - 70% alcohol
77143-004-082023-01-30C16284748780-1f386c64a-33fd-0266-e053-dadaa90a7c1a77143-004 - 70% alcohol
77143-004-102023-01-30C16284748780-1f386c64a-33fd-0266-e053-dadaa90a7c1a77143-004 - 70% alcohol
77143-004-112023-01-30C16284748780-1f386c64a-33fd-0266-e053-dadaa90a7c1a77143-004 - 70% alcohol
77143-004-122023-01-30C16284748780-1f386c64a-33fd-0266-e053-dadaa90a7c1a77143-004 - 70% alcohol
77143-004-182023-01-30C16284748780-1f386c64a-33fd-0266-e053-dadaa90a7c1a77143-004 - 70% alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77143-004-01Hand Sanitizer250 mL in 1 CONTAINERGEL2507
77143-004-02Hand Sanitizer236 mL in 1 CONTAINERGEL2367
77143-004-03Hand Sanitizer473 mL in 1 CONTAINERGEL4737
77143-004-05Hand Sanitizer946 mL in 1 CONTAINERGEL9467
77143-004-06Hand Sanitizer3785 mL in 1 CONTAINERGEL37857
77143-004-08Hand Sanitizer946 mL in 1 BOTTLEGEL9467
77143-004-10Hand Sanitizer250 mL in 1 BOTTLEGEL2507
77143-004-11Hand Sanitizer3785 mL in 1 BOTTLEGEL37857
77143-004-12Hand Sanitizer60 mL in 1 BOTTLEGEL607
77143-004-18Hand Sanitizer125 mL in 1 BOTTLEGEL1257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77143-004HAND SANITIZER (ALCOHOL) GEL [NATURATLALI S DE RL DE CV]7Legacy NDC, 10 package rows20201111_a58bb8b5-16e2-284a-e053-2a95a90a43cf.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77143-00477143-004-01, 77143-004-02, 77143-004-03, 77143-004-05, 77143-004-06, 77143-004-08, 77143-004-10, 77143-004-11, 77143-004-12, 77143-004-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
DMDM HYDANTOINBYR0546TOWIACT
ALCOHOL3K9958V90MACTIB
TRIETHANOLAMINE HYDRIODIDEDT98IT03JKIACT

Source Document#

Source XML · Source PDF

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
b3c914d8-f63d-0723-e053-2a95a90a88d4a58bb8b5-16e2-284a-e053-2a95a90a43cf2020-11-10WarningsExact identifier
spl id: b3c914d8-f63d-0723-e053-2a95a90a88d4
spl set id: a58bb8b5-16e2-284a-e053-2a95a90a43cf

Reported adverse events (FAERS/openFDA)#

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