FDA.reportPublic FDA data

Biogeno Care Hand Sanitizer Gel (Ethanol)

Manufacturer
DERMACOS KOREA
Effective date
2021-03-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:22

Label at a glance#

ProductBiogeno Care Hand Sanitizer Gel (Ethanol)
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product. Not recommended for infants.

Storage and handling

Store at room temperature (33.8oF-86oF, 1oC-30oC) and avoid cold or dry place. May discolor certain fabrics or surfaces. Harmful to wood finishes and plastics.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

OTC - PURPOSE SECTION

Antimicrobial, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin.
Recommended for repeated use.

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

  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product.
  • Not recommended for infants.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature (33.8oF-86oF, 1oC-30oC) and avoid cold or dry place.
  • May discolor certain fabrics or surfaces.
  • Harmful to wood finishes and plastics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Gel, Carbomer, Fragrance (Lemon), Glycerin, Green Tea Extract, Purified Water, Rosa Damascena (Rose) Flower Water, Sodium Hyaluronate, Triethanolamine.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Biogeno Care Hand Sanitizer Gel 500mLBiogeno Care Hand Sanitizer Gel 500mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77637-400-012022-07-29C16284748780-1e4f33bdf-9c9f-d8a0-e053-dadaa90a6e4ebeca59e0-c0f0-3a09-e053-2a95a90a03a7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77637-400-01Biogeno Care Hand Sanitizer Gel (Ethanol)500 mL in 1 BOTTLE, PUMPGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77637-400BIOGENO CARE HAND SANITIZER GEL (ETHANOL) (ALCOHOL) GEL [DERMACOS KOREA]1Legacy NDC, 1 package rows20210401_beca59e0-c0f0-3a09-e053-2a95a90a03a7.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
77637-40077637-400-01

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
ALOE VERA LEAFZY81Z83H0XIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
HYALURONATE SODIUMYSE9PPT4THIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

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
beca59e0-c0f1-3a09-e053-2a95a90a03a7beca59e0-c0f0-3a09-e053-2a95a90a03a72021-03-30WarningsExact identifier
spl id: beca59e0-c0f1-3a09-e053-2a95a90a03a7
spl set id: beca59e0-c0f0-3a09-e053-2a95a90a03a7

Reported adverse events (FAERS/openFDA)#

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