FDA.reportPublic FDA data

BIONAMICS

Manufacturer
ALA MEDICAL GROUP PTY LTD | Henan Bangruite Industry Co., Ltd
Effective date
2020-03-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:04:29

Label at a glance#

ProductBIONAMICS
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Hand sanitiser to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. Recommended for repeated use.

Dosage and administration

Place enough product in your palm to spread on both hands. Rub your hands together thoroughly until dry. Children under 6 years of age should be supervised by an adult when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active lngredient  

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol

Purpose 

OTC - PURPOSE SECTION

Antiseptic 

Uses 

INDICATIONS & USAGE SECTION


Hand sanitiser to help reduce bacteria that potentially

can cause disease. For use when soap and water are not available.

Recommended for repeated use.

Warnings  

WARNINGS SECTION

For external use only. Flammable.
Keep away from fire and flame.

Do not use  - in children less than 2 months of age.
                   - on open skin wounds.

When usin g this product Avoid contact with eyes. In case of eye
contact, rinse with water immediately.

Stop use and ask a doctor if irritation and rash appears and lasts.

Other information Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to spread on both hands.
  • Rub your hands together thoroughly until dry.
  • Children under 6 years of age should be supervised by an adult when using this product to avoid swallowing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

 Water, Glycerin, Tocopherol Acetate,
Carbopol Ultrez 21, Hydroxypropyl cellulose, Aloe Extract

Keep out of re ach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Centre immediately.

Product Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74198-001-012022-01-28C16284748780-1d6a99b39-a241-a426-e053-dadaa90af4c2BIONAMICS
74198-001-022022-01-28C16284748780-1d6a99b39-a241-a426-e053-dadaa90af4c2BIONAMICS
74198-001-032022-01-28C16284748780-1d6a99b39-a241-a426-e053-dadaa90af4c2BIONAMICS
74198-001-042022-01-28C16284748780-1d6a99b39-a241-a426-e053-dadaa90af4c2BIONAMICS
74198-001-062022-01-28C16284748780-1d6a99b39-a241-a426-e053-dadaa90af4c2BIONAMICS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74198-001-01BIONAMICS50 mL in 1 TUBEGEL501
74198-001-02BIONAMICS100 mL in 1 TUBEGEL1001
74198-001-03BIONAMICS250 mL in 1 BOTTLE, PLASTICGEL2501
74198-001-04BIONAMICS500 mL in 1 BOTTLE, PLASTICGEL5001
74198-001-06BIONAMICS1000 mL in 1 BOTTLE, PLASTICGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74198-001BIONAMICS (ETHYL ALCOHOL) GEL [ALA MEDICAL GROUP PTY LTD]1Legacy NDC, 5 package rows20200401_5f93e63c-0fe4-4fd5-82f2-d942b59c7005.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
74198-00174198-001-01, 74198-001-02, 74198-001-03, 74198-001-04, 74198-001-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
ALOEV5VD430YW9IACT

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
ba4306eb-1d7a-4af4-87f1-0affff758baa5f93e63c-0fe4-4fd5-82f2-d942b59c70052020-03-27WarningsExact identifier
spl id: ba4306eb-1d7a-4af4-87f1-0affff758baa
spl set id: 5f93e63c-0fe4-4fd5-82f2-d942b59c7005

Reported adverse events (FAERS/openFDA)#

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