FDA.reportPublic FDA data

GERM CLEAN

Manufacturer
NATURATLALI S DE RL DE CV
Effective date
2020-11-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:34:18

Label at a glance#

ProductGERM CLEAN
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Dosage and administration

Gently pull wipe from the dispenser feed. Wipe hands thoroughly with product and let dry. Discard wipe in trash.

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/w. 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.

OTC - WHEN USING SECTION

In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs.

Keep out of reach of children.

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

  • Gently pull wipe from the dispenser feed.
  • Wipe hands thoroughly with product and let dry.
  • Discard wipe in trash.

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, glycerin USP, benzyl alcohol, caprylyl/capryl oligoglucoside, iodopropynyl butylcarbamate, methylisothiazolinone, anhydrous citric acid, fragrance.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

350 mL NDC: 77143-006-01

PDP wipes - 350 mLPDP wipes - 350 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD2
1038558benzalkonium chloride 0.13 % Topical ClothSY2
1038558benzalkonium chloride 0.13 % Topical SwabSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77143-006-012023-01-30C16284748780-1f386c649-e411-0266-e053-dadaa90a7c1a77143-006 Toallitas sanitizantes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77143-006-01GERM CLEAN350 mL in 1 POUCHCLOTH3502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77143-006GERM CLEAN (BENZALKONIUM CHLORIDE) CLOTH [NATURATLALI S DE RL DE CV]2Legacy NDC, 1 package rows20201127_aa9647a1-648d-3e6b-e053-2a95a90a24fe.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77143-00677143-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
BENZYL ALCOHOLLKG8494WBHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
GLYCERYL OLEATE4PC054V79PIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FRAGARIA VESCA FRUIT JUICE59KX3YNN28IACT
FRAGRANCE LEMON ORC2001060K1725A7G95IACT

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
b5118ce5-67d1-acbc-e053-2995a90a4183aa9647a1-648d-3e6b-e053-2a95a90a24fe2020-11-27WarningsExact identifier
spl id: b5118ce5-67d1-acbc-e053-2995a90a4183
spl set id: aa9647a1-648d-3e6b-e053-2a95a90a24fe

Reported adverse events (FAERS/openFDA)#

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