FDA.reportPublic FDA data

Germs Be Gone Antibacterial Hand Sanitizing cream

Manufacturer
BRANDS INTERNATIONAL CORPORATION
Effective date
2021-08-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:55

Label at a glance#

ProductGerms Be Gone Antibacterial Non Scented
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

Rub thoroughly on hands for at least 30 seconds and allow to dry Supervise children when using this product to avoid swallowing. Adults and children over 2 years For occasional and domestic use

Storage and handling

Store between 15-30C (59-86F) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.05 %.

Purpose

OTC - PURPOSE SECTION

Antiseptic skin cleanser

Use

INDICATIONS & USAGE SECTION

To help reduce bacteria on hands.

Warnings

WARNINGS SECTION

For external use only.

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

  • Rub thoroughly on hands for at least 30 seconds and allow to dry
  • Supervise children when using this product to avoid swallowing.
  • Adults and children over 2 years
  • For occasional and domestic use

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Propylene Glycol, Isopropyl Myristate, Isopropyl Palmitate, Stearyl Alcohol, Ceteareth-20, Glycerin, Glyceryl Stearate,
Caprylic/Capric Triglyceride, Stearic Acid, Glycol Stearate, Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera Oil (Coconut),
Petroleum Jelly, Vitamin E (Tocopherol), DMDM Hydantoin, Allantoin, Aloe Barbadensis Leaf Extract

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

33

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094748benzalkonium chloride 0.13 % Topical CreamPSN1
1094748benzalkonium chloride 1.3 MG/ML Topical CreamSCD1
1094748benzalkonium chloride 0.13 % Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50157-523-502025-01-30C16284748780-12cef2736-608c-d83d-e063-dadaa90ab31fGerms Be Gone Antibacterial Hand Sanitizing cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50157-523-50Germs Be Gone AntibacterialNon Scented50 mL in 1 BOTTLECREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50157-523GERMS BE GONE ANTIBACTERIAL NON SCENTED (ANTISEPTIC HAND CREAM) CREAM [BRANDS INTERNATIONAL CORPORATION]1Legacy NDC, 1 package rows20210816_c989841f-5785-a5e6-e053-2a95a90a0274.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50157-52350157-523-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
STEARYL ALCOHOL2KR89I4H1YIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
SUNFLOWER OIL3W1JG795YIIACT
COCONUT OILQ9L0O73W7LIACT
PETROLATUM4T6H12BN9UIACT
TRICAPRYLIN6P92858988IACT
ALLANTOIN344S277G0ZIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DMDM HYDANTOINBYR0546TOWIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ISOPROPYL PALMITATE8CRQ2TH63MIACT

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
c98984c9-b666-0305-e053-2a95a90a68ccc989841f-5785-a5e6-e053-2a95a90a02742021-08-14WarningsExact identifier
spl id: c98984c9-b666-0305-e053-2a95a90a68cc
spl set id: c989841f-5785-a5e6-e053-2a95a90a0274

Reported adverse events (FAERS/openFDA)#

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