FDA.reportPublic FDA data

Vivitar Ethyl Alcohol Antiseptic Hand Wipes

Manufacturer
Cixi Fanhua Non Woven Products Co., Ltd
Effective date
2021-04-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:39:58

Label at a glance#

ProductVivitar Ethyl Alcohol Antiseptic Hand Wipes
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

• hand wipes to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available

Dosage and administration

• open pouch by peeling back seal • wet hands thoroughly with product and allow to dry without wiping • reseal pouch after each use to preserve moisture • supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

store below 110ºF (43ºC)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• hand wipes to decrease bacteria on the skin
• recommended for repeated use
• for use when soap and water are not available

Warnings

WARNINGS SECTION

Flammable, keep away from fire/flame
For external use only

Do not use
• in children less than 12 months of age
• on open skin wounds
• as a baby wipe

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 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• open pouch by peeling back seal
• wet hands thoroughly with product and allow to dry without wiping
• reseal pouch after each use to preserve moisture
• supervise children under 6 years of age when using this product to avoid swallowing

Other information

STORAGE AND HANDLING SECTION

store below 110ºF (43ºC)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alkyl dimethyl benzyl ammonium chloride, aloe extract, alpha tocopherol, decyl glucoside, glycerin, phenoxyethanol, polysorbate 20, water

Questions? +1-800-592-9541

OTC - QUESTIONS SECTION

You may also report serious side effects to this phone number.
Monday - Sunday: 24x7

SPL UNCLASSIFIED SECTION

Distributed by

Sakar International

195 Carter Drive,
Edison, NJ 08817

www.vivitar.com

Made in China

VIVITAR®

©2021

CAUTION : KEEP OUT OF REACH OF CHILDREN AND PETS.

Keep All Relevant Information for Future Reference.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1307051ethanol 75 % Medicated PadPSN2
1307051ethanol 0.75 ML/ML Medicated PadSCD2
1307051ethanol 75 % Hand Sanitizer WipesSY2
1307051ethyl alcohol 75 % Topical ClothSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54826-005-012023-01-30C16284748780-1f386c64a-41eb-0266-e053-dadaa90a7c1aEthyl Alcohol Antiseptic Hand Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54826-005-01Vivitar Ethyl Alcohol Antiseptic Hand Wipes4.9 mL in 1 PACKAGECLOTH4.92
54826-005-01Vivitar Ethyl Alcohol Antiseptic Hand Wipes60 in 1 CANISTERCLOTH602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54826-005VIVITAR ETHYL ALCOHOL ANTISEPTIC HAND WIPES (ETHYL ALCOHOL) CLOTH [CIXI FANHUA NON WOVEN PRODUCTS CO., LTD]2Legacy NDC, 2 package rows20210427_515d3659-cf06-4b2c-bc64-6c91e245784a.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
54826-00554826-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
ALOEV5VD430YW9IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
DECYL GLUCOSIDEZ17H97EA6YIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
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
0b10c678-0f93-4d0c-9e73-6d619faa3ef8515d3659-cf06-4b2c-bc64-6c91e245784a2021-04-26WarningsExact identifier
spl id: 0b10c678-0f93-4d0c-9e73-6d619faa3ef8
spl set id: 515d3659-cf06-4b2c-bc64-6c91e245784a

Reported adverse events (FAERS/openFDA)#

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