FDA.reportPublic FDA data

Sentinel ANTIBACTERIAL ALCOHOL WIPES

Manufacturer
Amrapur Overseas Incorporated
Effective date
2020-11-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:33:48

Label at a glance#

ProductSentinel ANTIBACTERIAL ALCOHOL WIPES
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Helps reduce bacteria on the skin that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

Adults and children 6 years and over Apply wipe thoroughly to hands as desired. Allow hands to dry. Children under 6 years ask a doctor before use

Storage and handling

Store in cool and dry place. Keep away from heat and direct sunlight.

Label contents#

Full prescribing information#

Active ingredient (in each wipe)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75%(v/v)

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

Helps reduce bacteria on the skin that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only.

Avoid touching eyes. In case of eye contact, flush thoroughly with water.

Avoid contact with broken skin.

Don't flush into toilet.

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

Flammable: Keep away from fire or flame.

Do not use: On children less than 2 months of age, on open skin wounds, infections and open sores.

Ask a doctor before use if you have: Skin cuts, Infections or sores.

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 at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years and over

Apply wipe thoroughly to hands as desired. Allow hands to dry.

Children under 6 years

ask a doctor before use

Other information:

STORAGE AND HANDLING SECTION

Store in cool and dry place. Keep away from heat and direct sunlight.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water(Aqua), Glycerin

Questions?:

OTC - QUESTIONS SECTION

Please contact (714) 893-8808. M-F 8am - 5pm

SPL UNCLASSIFIED SECTION

Wipe Dimensions:

5.9 in. x 6.3 in.

(15 cm x 16 cm)

75% ALCOHOL

Directions:

1. Open the lid

2. Open the seal

3. Pull out the wipes one by one and use

4. Please reseal after use to prevent moisture loss

5. Close the lid

Manufactured for AMRAPUR OVERSEAS INC.

Corona CA.

Sentinel is a ® registered trademark of AMRAPUR OVERSEAS INC. Corona Ca

Made in China

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

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
80147-075-502022-01-28C16284748780-1d6a99b39-e615-a426-e053-dadaa90af4c2by SENTINEL ® ​ ANTIBACTERIAL ALCOHOL WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80147-075-50Sentinel ANTIBACTERIAL ALCOHOL WIPES50 in 1 POUCHCLOTH501
80147-075-50Sentinel ANTIBACTERIAL ALCOHOL WIPES6 mL in 1 PACKAGECLOTH61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80147-075SENTINEL ANTIBACTERIAL ALCOHOL WIPES (ALCOHOL) CLOTH [AMRAPUR OVERSEAS INCORPORATED]1Legacy NDC, 2 package rows20201118_72560272-f77a-4f49-a72b-a8f6999ff1aa.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80147-07580147-075-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

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
b478b160-668a-4b37-b032-c7d1c54e32d772560272-f77a-4f49-a72b-a8f6999ff1aa2020-11-16WarningsExact identifier
spl id: b478b160-668a-4b37-b032-c7d1c54e32d7
spl set id: 72560272-f77a-4f49-a72b-a8f6999ff1aa

Reported adverse events (FAERS/openFDA)#

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