FDA.reportPublic FDA data

BIOPERFECT Hand Sanitizing Wipes (Alcohol Free)

Manufacturer
Shandong Renrui Biotechnology Co, Ltd.
Effective date
2020-08-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:24

Label at a glance#

ProductBIOPERFECT Hand Sanitizing Wipes (Alcohol Free)
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry. Discard wipe in trash receptacle after use. Do not flush. Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

Hand sanitizing to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash appears and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry. Discard wipe in trash receptacle after use. Do not flush. Children under 6 years of age should be supervised when using this product.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Phenoxyethanol, Ethylglycerin, Propylene Glycol,Citric Acid

Package Labeling:100pcs

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:150pcs

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN1
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD1
1038558benzalkonium chloride 0.13 % Topical ClothSY1
1038558benzalkonium chloride 0.13 % Topical SwabSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY1
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77985-003-012022-01-28C16284748780-1d6a99b39-5feb-a426-e053-dadaa90af4c2BIOPERFECT Hand Sanitizing Wipes (Alcohol Free)
77985-003-022022-01-28C16284748780-1d6a99b39-5feb-a426-e053-dadaa90af4c2BIOPERFECT Hand Sanitizing Wipes (Alcohol Free)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77985-003-01BIOPERFECT Hand Sanitizing Wipes (Alcohol Free)100 in 1 CANISTERCLOTH1001
77985-003-01BIOPERFECT Hand Sanitizing Wipes (Alcohol Free)4.7 mL in 1 PATCHCLOTH4.71
77985-003-02BIOPERFECT Hand Sanitizing Wipes (Alcohol Free)9.4 mL in 1 PATCHCLOTH9.41
77985-003-02BIOPERFECT Hand Sanitizing Wipes (Alcohol Free)150 in 1 CANISTERCLOTH1501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77985-003BIOPERFECT HAND SANITIZING WIPES (ALCOHOL FREE) (BENZALKONIUM CHLORIDE) CLOTH [SHANDONG RENRUI BIOTECHNOLOGY CO, LTD.]1Legacy NDC, 4 package rows20200901_adf3d489-a86a-16a3-e053-2995a90a7012.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
77985-00377985-003-01, 77985-003-02

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
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
adf3d489-a86b-16a3-e053-2995a90a7012adf3d489-a86a-16a3-e053-2995a90a70122020-08-28WarningsExact identifier
spl id: adf3d489-a86b-16a3-e053-2995a90a7012
spl set id: adf3d489-a86a-16a3-e053-2995a90a7012

Reported adverse events (FAERS/openFDA)#

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