FDA.reportPublic FDA data

Reborncare hand sanitizer (100mL)

Manufacturer
Reborncare | Venice Cosmetic | Reborncare Co., Ltd.
Effective date
2020-07-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:22:16

Label at a glance#

ProductReborncare hand sanitizer (100mL)
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Hand sanitizer for decreasing bacteria on skin

Dosage and administration

Apply the adequate amount on hands

Label contents#

Full prescribing information#

Active ingedient

OTC - ACTIVE INGREDIENT SECTION

Ethanol (ethyl alcohol) (70%)

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer for decreasing bacteria on skin

Warnings

WARNINGS SECTION

For external use only

Do not use if you are allergic to any of the ingredients

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. avoid contact with broken, irritated, or itching skin. Do not puncture or incinerate.

Stop use and ask a doctor if irritation or redness develops and the condition persists for more than 72 hours.

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply the adequate amount on hands

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Tocopheryl

Reborncare hand sanitizer (100mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3_label_100ml3_label_100ml

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
79486-100-012022-01-28C16284748780-1d6a99b39-431a-a426-e053-dadaa90af4c2Reborncare hand sanitizer (100mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79486-100-01Reborncare hand sanitizer (100mL)100 mL in 1 BOTTLEGEL1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79486-100REBORNCARE HAND SANITIZER (100ML) (ETHYL ALCOHOL) GEL [REBORNCARE]3Legacy NDC, 1 package rows20200723_a9e1d9e0-91d2-0ccb-e053-2a95a90aa7d4.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79486-10079486-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
ALCOHOL3K9958V90MACTIB
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
ab011d90-a69d-7d86-e053-2a95a90a0d2ba9e1d9e0-91d2-0ccb-e053-2a95a90aa7d42020-07-22WarningsExact identifier
spl id: ab011d90-a69d-7d86-e053-2a95a90a0d2b
spl set id: a9e1d9e0-91d2-0ccb-e053-2a95a90aa7d4

Reported adverse events (FAERS/openFDA)#

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