FDA.reportPublic FDA data

BC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES

Manufacturer
BAC & CLARK COM SH.P.K.
Effective date
2021-02-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:08

Label at a glance#

ProductBC Hygiene MAX 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 the lid and pull out the first wipe • pull wipe apart at the perforated seam • wet hands thoroughly with product and allow to dry without wiping • keep container tightly closed to keep wipes from drying out • do not flush • supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

• store between 15-30°C (59-86°F) • avoid freezing and excessive heat above 40°C (104°F)

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 2 months of age
• on open skin wounds

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 the lid and pull out the first wipe
• pull wipe apart at the perforated seam
• wet hands thoroughly with product and allow to dry without wiping
• keep container tightly closed to keep wipes from drying out
• do not flush
• supervise children under 6 years of age when using this product to avoid swallowing

Other information

STORAGE AND HANDLING SECTION

• store between 15-30°C (59-86°F)
• avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

ethylenediaminetetraacetic acid, fragrance (parfum), isopropyl alcohol, water (aqua)

Questions?

OTC - QUESTIONS SECTION

+1-504-609-9559
You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

75% Ethyl Alcohol

Bac & Clark Quality

Manufactured By: Bac & Clark Com S.H.P.K
P.N. LLAPLLASELLE GRACANICE, PRISHTINA, KOSOVO 10000

Country of origin: Kosovo

www.bacclark.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bcmax1Bcmax1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1307051ethanol 75 % Medicated PadPSN1
1307051ethanol 0.75 ML/ML Medicated PadSCD1
1307051ethanol 75 % Hand Sanitizer WipesSY1
1307051ethyl alcohol 75 % Topical ClothSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81567-101-102022-07-29C16284748780-1e4f33bdf-9ce3-d8a0-e053-dadaa90a6e4eBC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES
81567-101-122022-07-29C16284748780-1e4f33bdf-9ce3-d8a0-e053-dadaa90a6e4eBC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES
81567-101-152022-07-29C16284748780-1e4f33bdf-9ce3-d8a0-e053-dadaa90a6e4eBC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES
81567-101-162022-07-29C16284748780-1e4f33bdf-9ce3-d8a0-e053-dadaa90a6e4eBC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES
81567-101-482022-07-29C16284748780-1e4f33bdf-9ce3-d8a0-e053-dadaa90a6e4eBC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES
81567-101-502022-07-29C16284748780-1e4f33bdf-9ce3-d8a0-e053-dadaa90a6e4eBC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES
81567-101-752022-07-29C16284748780-1e4f33bdf-9ce3-d8a0-e053-dadaa90a6e4eBC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES
81567-101-802022-07-29C16284748780-1e4f33bdf-9ce3-d8a0-e053-dadaa90a6e4eBC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81567-101-10BC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES3 mL in 1 PACKAGECLOTH31
81567-101-10BC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES100 in 1 BOXCLOTH1001
81567-101-12BC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES120 in 1 BOXCLOTH1201
81567-101-12BC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES3 mL in 1 PACKAGECLOTH31
81567-101-15BC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES3 mL in 1 PACKAGECLOTH31
81567-101-15BC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES150 in 1 BOXCLOTH1501
81567-101-16BC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES160 in 1 BOXCLOTH1601
81567-101-16BC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES3 mL in 1 PACKAGECLOTH31
81567-101-48BC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES48 in 1 BOXCLOTH481
81567-101-48BC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES3 mL in 1 PACKAGECLOTH31
81567-101-50BC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES500 in 1 BOXCLOTH5001
81567-101-50BC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES3.9 mL in 1 PACKAGECLOTH3.91
81567-101-75BC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES3 mL in 1 PACKAGECLOTH31
81567-101-75BC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES75 in 1 BOXCLOTH751
81567-101-80BC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES3 mL in 1 PACKAGECLOTH31
81567-101-80BC Hygiene MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES80 in 1 BOXCLOTH801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81567-101BC HYGIENE MAX ETHYL ALCOHOL ANTISEPTIC HAND WIPES (ETHYL ALCOHOL) CLOTH [BAC & CLARK COM SH.P.K.]1Legacy NDC, 16 package rows20210216_108e3e7c-1d86-4d76-80d8-dc9e127febf8.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
81567-10181567-101-48, 81567-101-75, 81567-101-80, 81567-101-10, 81567-101-12, 81567-101-15, 81567-101-16, 81567-101-50

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
ALCOHOL3K9958V90MACTIB
EDETIC ACID9G34HU7RV0IACT
ISOPROPYL ALCOHOLND2M416302IACT
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
709973d6-9314-487d-ae94-c013582d206c108e3e7c-1d86-4d76-80d8-dc9e127febf82021-02-12WarningsExact identifier
spl id: 709973d6-9314-487d-ae94-c013582d206c
spl set id: 108e3e7c-1d86-4d76-80d8-dc9e127febf8

Reported adverse events (FAERS/openFDA)#

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