FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
NATURATLALI S DE RL DE CV
Effective date
2021-02-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:38:29

Label at a glance#

ProductHand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
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

Benzalkonium Chloride 0.13% w/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.

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

water, hydroxyethylcellulose, glycerin, methylparaben, propylparaben, propylene glycol, DMDM Hydantoin, FD&C Blue No 1

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mL NDC: 77143-002-02

Nat 500mLNat 500mL

250 mL NDC: 77143-002-03

Nat 250mLNat 250mL

5000 mL NDC: 77143-002-04 5 L5 L

1000 mL NDC: 77143-002-05 Alpha 1LAlpha 1L

1000 mL NDC: 77143-002-06 CP 1LCP 1L

500 mL NDC: 77143-002-07 CP 500mLCP 500mL

500 mL NDC: 77143-002-08 Alpha 500mlAlpha 500ml

250 mL NDC: 77143-003-09 Alpha 250Alpha 250

5000 mL NDC: 77143-002-10 alpha 5Lalpha 5L

3785 mL NDC: 77143-002-11 CP galCP gal

5000 mL NDC: 77143-002-12 Q5LQ5L

250 mL NDC: 77143-002-13 quarter 250quarter 250

500 mL NDC: 77143-002-14 quarter 500quarter 500

1000 mL NDC: 77143-002-15 1Lquarter1Lquarter

3785 mL NDC: 77143-002-16 gal quartergal quarter

3785 mL NDC: 77143-002-17

Nat 3785mLNat 3785mL

100 mL NDC: 77143-002-22

PDP 100 ml QuaterPDP 100 ml Quater

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1098199benzalkonium chloride 0.13 % Topical GelPSN5
1098199benzalkonium chloride 0.0013 MG/MG Topical GelSCD5
1098199benzalkonium chloride 0.13 % Topical GelSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77143-002-022023-01-30C16284748780-1f386c649-c43f-0266-e053-dadaa90a7c1a77143-002 Benzalkonium Chloride, Alcohol Free
77143-002-032023-01-30C16284748780-1f386c649-c43f-0266-e053-dadaa90a7c1a77143-002 Benzalkonium Chloride, Alcohol Free
77143-002-042023-01-30C16284748780-1f386c649-c43f-0266-e053-dadaa90a7c1a77143-002 Benzalkonium Chloride, Alcohol Free
77143-002-052023-01-30C16284748780-1f386c649-c43f-0266-e053-dadaa90a7c1a77143-002 Benzalkonium Chloride, Alcohol Free
77143-002-062023-01-30C16284748780-1f386c649-c43f-0266-e053-dadaa90a7c1a77143-002 Benzalkonium Chloride, Alcohol Free
77143-002-072023-01-30C16284748780-1f386c649-c43f-0266-e053-dadaa90a7c1a77143-002 Benzalkonium Chloride, Alcohol Free
77143-002-082023-01-30C16284748780-1f386c649-c43f-0266-e053-dadaa90a7c1a77143-002 Benzalkonium Chloride, Alcohol Free
77143-002-092023-01-30C16284748780-1f386c649-c43f-0266-e053-dadaa90a7c1a77143-002 Benzalkonium Chloride, Alcohol Free
77143-002-102023-01-30C16284748780-1f386c649-c43f-0266-e053-dadaa90a7c1a77143-002 Benzalkonium Chloride, Alcohol Free
77143-002-112023-01-30C16284748780-1f386c649-c43f-0266-e053-dadaa90a7c1a77143-002 Benzalkonium Chloride, Alcohol Free
77143-002-122023-01-30C16284748780-1f386c649-c43f-0266-e053-dadaa90a7c1a77143-002 Benzalkonium Chloride, Alcohol Free
77143-002-132023-01-30C16284748780-1f386c649-c43f-0266-e053-dadaa90a7c1a77143-002 Benzalkonium Chloride, Alcohol Free
77143-002-142023-01-30C16284748780-1f386c649-c43f-0266-e053-dadaa90a7c1a77143-002 Benzalkonium Chloride, Alcohol Free
77143-002-152023-01-30C16284748780-1f386c649-c43f-0266-e053-dadaa90a7c1a77143-002 Benzalkonium Chloride, Alcohol Free
77143-002-162023-01-30C16284748780-1f386c649-c43f-0266-e053-dadaa90a7c1a77143-002 Benzalkonium Chloride, Alcohol Free
77143-002-172023-01-30C16284748780-1f386c649-c43f-0266-e053-dadaa90a7c1a77143-002 Benzalkonium Chloride, Alcohol Free
77143-002-222023-01-30C16284748780-1f386c649-c43f-0266-e053-dadaa90a7c1a77143-002 Benzalkonium Chloride, Alcohol Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77143-002-02Hand Sanitizer500 mL in 1 BOTTLEGEL5005
77143-002-03Hand Sanitizer250 mL in 1 BOTTLEGEL2505
77143-002-04Hand Sanitizer5000 mL in 1 CONTAINERGEL50005
77143-002-05Hand Sanitizer1000 mL in 1 BOTTLEGEL10005
77143-002-06Hand Sanitizer1000 mL in 1 BOTTLEGEL10005
77143-002-07Hand Sanitizer500 mL in 1 BOTTLEGEL5005
77143-002-08Hand Sanitizer500 mL in 1 BOTTLEGEL5005
77143-002-09Hand Sanitizer250 mL in 1 BOTTLEGEL2505
77143-002-10Hand Sanitizer5000 mL in 1 CONTAINERGEL50005
77143-002-11Hand Sanitizer3785 mL in 1 CONTAINERGEL37855
77143-002-12Hand Sanitizer5000 mL in 1 BOTTLEGEL50005
77143-002-13Hand Sanitizer250 mL in 1 BOTTLEGEL2505
77143-002-14Hand Sanitizer500 mL in 1 BOTTLEGEL5005
77143-002-15Hand Sanitizer1000 mL in 1 BOTTLEGEL10005
77143-002-16Hand Sanitizer3785 mL in 1 CONTAINERGEL37855
77143-002-17Hand Sanitizer3785 mL in 1 CONTAINERGEL37855
77143-002-22Hand Sanitizer100 mL in 1 BOTTLEGEL1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77143-002HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [NATURATLALI S DE RL DE CV]5Legacy NDC, 17 package rows20210224_a6bd09d4-ebea-0f2d-e053-2a95a90a5f30.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77143-00277143-002-05, 77143-002-10, 77143-002-06, 77143-002-02, 77143-002-03, 77143-002-04, 77143-002-07, 77143-002-08, 77143-002-09, 77143-002-11, 77143-002-12, 77143-002-13, 77143-002-14, 77143-002-15, 77143-002-16, 77143-002-17, 77143-002-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
WATER059QF0KO0RIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
DMDM HYDANTOINBYR0546TOWIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
DIPROPYLENE GLYCOLE107L85C40IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
bc0b706a-f032-f75b-e053-2a95a90a1086a6bd09d4-ebea-0f2d-e053-2a95a90a5f302021-02-23WarningsExact identifier
spl id: bc0b706a-f032-f75b-e053-2a95a90a1086
spl set id: a6bd09d4-ebea-0f2d-e053-2a95a90a5f30

Reported adverse events (FAERS/openFDA)#

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