FDA.reportPublic FDA data

Antibacterial Wipes

Manufacturer
FuYang YangYang Health Technology Co. Ltd
Effective date
2020-08-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:27

Label at a glance#

ProductAntibacterial Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

Storage and handling

Keep containers tightly closed in a dry, cool and well-ventilated place. Recommended storage temperature: 32F to 104F(0C to 4C).

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% w/w. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Decreases bacteria and germs on the skin that could cause disease.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • irritation and redness develop.
  • condition persists 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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and allow to dry without wiping.
  • For children under 6, use only under adult supervision.
  • Not recommended for infants.

Other information

STORAGE AND HANDLING SECTION

  • Keep containers tightly closed in a dry, cool and well-ventilated place.
  • Recommended storage temperature: 32F to 104F(0C to 4C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, fragrance, phenoxyethanol, polysorbate 20, propylene glycol, tocopheryl acetate, water.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10 Wipes in 1 BAG NDC: 76641-011-04 Package LabelPackage Label

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
76641-011-042022-01-28C16284748780-1d6a99b39-ae26-a426-e053-dadaa90af4c2ac827719-e81b-621d-e053-2995a90a21ed

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76641-011-04Antibacterial Wipes48.6 g in 1 BAGCLOTH48.61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76641-011ANTIBACTERIAL WIPES (HAND SANITIZER) CLOTH [FUYANG YANGYANG HEALTH TECHNOLOGY CO. LTD]1Legacy NDC, 1 package rows20200812_ac827719-e81b-621d-e053-2995a90a21ed.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76641-01176641-011-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOEV5VD430YW9IACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
ac826b40-1003-2fb3-e053-2a95a90a48b3ac827719-e81b-621d-e053-2995a90a21ed2020-08-11WarningsExact identifier
spl id: ac826b40-1003-2fb3-e053-2a95a90a48b3
spl set id: ac827719-e81b-621d-e053-2995a90a21ed

Reported adverse events (FAERS/openFDA)#

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