FDA.reportPublic FDA data

HiGeen ® ​ Antiseptic Hand Sanitizer Gel with Vitamin Beads For Kids & Adults Bitty & Mitty

Manufacturer
SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO)
Effective date
2021-12-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:48:13

Label at a glance#

ProductHiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads For Kids and Adults Bitty and Mitty
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

• for handwashing to decrease bacteria on the skin. • recommended for repeated use.

Dosage and administration

• wet hands thoroughly with product and allow to dry without wiping. • supervise children in the use of this product.

Storage and handling

• store at 20° to 25°C (68° to 77°F). • may discolor certain fabrics.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% V/V

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• for handwashing to decrease bacteria on the skin. • recommended for repeated use.

Warnings

WARNINGS SECTION

Flammable, keep away from fire or flame.
For external use only.
When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if • irritation and redness develops. • condition persist for more than 72 hours.

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

• wet hands thoroughly with product and allow to dry without wiping. • supervise children in the use of this product.

Other information

STORAGE AND HANDLING SECTION

• store at 20° to 25°C (68° to 77°F). • may discolor certain fabrics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates (c10-30 alkyl acrylate crosspolymer), benzophenone-3, carbomer, cellulose, D&C Yellow No.10, FD&C Blue No. 1, fragrance, glycerin, hydroxypropyl methylcellulose, lactose, retinyl palmitate (vitamin A palmitate), tocopheryl acetate (vitamin E acetate), triethanolamine, water (aqua).

Questions or comments?

OTC - QUESTIONS SECTION

call   +1-419-322-4731
available from Monday to Friday (8 am – 4 pm).
You may report serious side effects to this phone number.

SPL UNCLASSIFIED SECTION

NO WATER
NO SOAP

Manufactured by:
Sukhtian Households and Toiletries Manufacturing Co. Ltd.
Al Hizam street, Abu Alanda,
Amman, Jordan 11118
P.O.BOX : 1027

Made in Jordan

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71490-033-032024-01-30C16284748780-11030e365-18ee-111a-e063-dadaa90a10e2HiGeen ® ​ Antiseptic Hand Sanitizer Gel with Vitamin Beads For Kids & Adults Bitty & Mitty
71490-033-052024-01-30C16284748780-11030e365-18ee-111a-e063-dadaa90a10e2HiGeen ® ​ Antiseptic Hand Sanitizer Gel with Vitamin Beads For Kids & Adults Bitty & Mitty

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71490-033-03HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads For Kids and Adults Bitty and Mitty50 mL in 1 BOTTLEGEL503
71490-033-05HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads For Kids and Adults Bitty and Mitty80 mL in 1 BOTTLEGEL803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71490-033HIGEEN ANTISEPTIC HAND SANITIZER GEL WITH VITAMIN BEADS FOR KIDS AND ADULTS BITTY AND MITTY (ETHYL ALCOHOL) GEL [SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO)]3Legacy NDC, 2 package rows20220212_d1026d47-8865-420f-a2e6-513af027f624.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71490-03371490-033-05, 71490-033-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
OXYBENZONE95OOS7VE0YIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
POWDERED CELLULOSESMD1X3XO9MIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

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
72b772c0-8ddb-460b-9ad7-6a50644b73c4d1026d47-8865-420f-a2e6-513af027f6242021-12-08WarningsExact identifier
spl id: 72b772c0-8ddb-460b-9ad7-6a50644b73c4
spl set id: d1026d47-8865-420f-a2e6-513af027f624

Reported adverse events (FAERS/openFDA)#

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