FDA.reportPublic FDA data

Bernal Premium Alcohol Wipe

Manufacturer
Newport MFG LLC
Effective date
2020-10-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:44

Label at a glance#

ProductBernal Premium Alcohol Wipe
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

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

Storage and handling

Store between 20-25C (67-77F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% v/v. Purpose: Antimicrobial

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

  • to decrease bacteria on skin
  • recommended for repeated use

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

  • Do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.
  • Avoid contact with broken skin
  • Do not inhale or ingest

OTC - STOP USE SECTION

  • Irritation or redness develops.
  • 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

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

Other information

STORAGE AND HANDLING SECTION

  • Store between 20-25C (67-77F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Citrus Limon Peel Oil, D-Limonene, Glycerin, Tocopherol Acetate (Vitamin E), Water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80479-175-01 Single Wipe packaging pouch80479-175-01 Single Wipe packaging pouch3 mL NDC: 80479-175-40 80479-175-40 Principal Packaging Box Wipe 40 Pack80479-175-40 Principal Packaging Box Wipe 40 Pack

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80479-175-012022-01-28C16284748780-1d6a99b39-64b8-a426-e053-dadaa90af4c2Bernal Premium Alcohol Wipe
80479-175-152022-01-28C16284748780-1d6a99b39-64b8-a426-e053-dadaa90af4c2Bernal Premium Alcohol Wipe
80479-175-402022-01-28C16284748780-1d6a99b39-64b8-a426-e053-dadaa90af4c2Bernal Premium Alcohol Wipe
80479-175-992022-01-28C16284748780-1d6a99b39-64b8-a426-e053-dadaa90af4c2Bernal Premium Alcohol Wipe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80479-175-01Bernal Premium Alcohol Wipe3 mL in 1 POUCHCLOTH31
80479-175-15Bernal Premium Alcohol Wipe3 mL in 1 POUCHCLOTH31
80479-175-15Bernal Premium Alcohol Wipe15 in 1 BOXCLOTH151
80479-175-40Bernal Premium Alcohol Wipe3 mL in 1 POUCHCLOTH31
80479-175-40Bernal Premium Alcohol Wipe40 in 1 BOXCLOTH401
80479-175-99Bernal Premium Alcohol Wipe100 in 1 BAGCLOTH1001
80479-175-99Bernal Premium Alcohol Wipe3 mL in 1 POUCHCLOTH31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80479-175BERNAL PREMIUM ALCOHOL WIPE (ALCOHOL) CLOTH [NEWPORT MFG LLC]1Legacy NDC, 7 package rows20201102_b235d710-b2a7-1dd7-e053-2a95a90a7ca2.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
80479-17580479-175-15, 80479-175-99, 80479-175-40, 80479-175-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIMONENE, (+)-GFD7C86Q1WIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
LEMON OILI9GRO824LLIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
b235d593-1240-0576-e053-2995a90a8f84b235d710-b2a7-1dd7-e053-2a95a90a7ca22020-10-21WarningsExact identifier
spl id: b235d593-1240-0576-e053-2995a90a8f84
spl set id: b235d710-b2a7-1dd7-e053-2a95a90a7ca2

Reported adverse events (FAERS/openFDA)#

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