FDA.reportPublic FDA data

BioRestore Hand Sanitizing Wipes

Manufacturer
UNIVERSAL CONSUMER BRANDS INC
Effective date
2021-01-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:58

Label at a glance#

ProductBioRestore Hand Sanitizing Wipes
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Wipe thoroughly into hands for atleast 30 seconds. Allow to dry. Children under 6 years of age should be supervised when using product.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethanol Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

Antiseptic skin cleanser, Kills harmful bacteria

Warnings

WARNINGS SECTION

  • For external use only.
  • Keep away from fire or flame

When using

OTC - WHEN USING SECTION

When using this product keep out of eyes. If contact with eyes occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

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

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wipe thoroughly into hands for atleast 30 seconds. Allow to dry.
  • Children under 6 years of age should be supervised when using product.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Fragrance, Isopropyl alcohol, glycerin, denatonium benzoate

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1489307ethanol 70 % Medicated PadPSN1
1489307ethanol 0.7 ML/ML Medicated PadSCD1
1489307ethanol 70 % Medicated PadSY1
1489307ethanol 70 % Medicated WipesSY1
1489307ethyl alcohol 70 % ClothSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78489-003-802022-07-29C16284748780-1e4f33bdf-9b8a-d8a0-e053-dadaa90a6e4eBIORESTORE- Hand Sanitizing wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78489-003-80BioRestore Hand Sanitizing Wipes80 in 1 CONTAINERCLOTH801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78489-003BIORESTORE HAND SANITIZING WIPES (ETHYL ALCOHOL) CLOTH [UNIVERSAL CONSUMER BRANDS INC]1Legacy NDC, 1 package rows20210115_b8e681c6-bf18-3eba-e053-2a95a90a1c6e.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78489-00378489-003-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ISOPROPYL ALCOHOLND2M416302IACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
GLYCERINPDC6A3C0OXIACT

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
b8e681d3-34fd-0f64-e053-2995a90a5aeab8e681c6-bf18-3eba-e053-2a95a90a1c6e2021-01-14WarningsExact identifier
spl id: b8e681d3-34fd-0f64-e053-2995a90a5aea
spl set id: b8e681c6-bf18-3eba-e053-2a95a90a1c6e

Reported adverse events (FAERS/openFDA)#

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