FDA.reportPublic FDA data

San-E-Pur ANTISEPTIC WIPES

Manufacturer
Acor Foods-csftn Llc
Effective date
2020-10-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:31:45

Label at a glance#

ProductSan-E-Pur ANTISEPTIC WIPES
Active ingredientALCOHOL
Label structure12 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

• wet hands thoroughly with product and allow to dry without wiping • 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

• wet hands thoroughly with product and allow to dry without wiping • 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

benzalkonium chloride, glycerin, water

Questions?

OTC - QUESTIONS SECTION

+1-901-212-1386

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

SPL UNCLASSIFIED SECTION

SAFE FOR SKIN

KILLS GERMS

Helps in Reducing Bacteria 

Distributed by:
ACOR FOODS-CSFTN LLC
1400 Veterans Memorial HWY SE
Suite 134#374
Mableton, GA 30126

made in China
www.san-e-pur.com

( 5.9 in x 7.8 in )
( 15 cm x 20 cm )
Wipe Size


PROTECT CARE

San-E-Pur antiseptic wipes are safe for skin and are perfect for cleaning and reducing bacteria from hands.
Ideal for sanitizing and eliminating contaminates when soap and water is not available. Our alcohol-based
formula effectively reduces bacteria as well as serves as an antiseptic agent

DIRECTIONS FOR USE

Adults and children 2 years and over: Rub thoroughly into hands for at least 30 seconds. Allow to dry. For occasional and personal domestic use. Supervise children when they use this product.

RECOMMENDED USE

  • Antibacterial (skin) cleanser.
  • Antiseptic (skin) cleanser.
  • Effective in destroying (harmful) bacteria to provide antiseptic cleansing.
  • For personal hand hygiene to help prevent the spread of bacteria.
  • Kills harmful bacteria/germs.

Store in a cool and dry place, away from direct sunlight.

Do not use if the inner seal is broken.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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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
77585-101-012022-01-28C16284748780-1d6a99b39-63b8-a426-e053-dadaa90af4c2San-E-Pur ANTISEPTIC WIPES
77585-101-022022-01-28C16284748780-1d6a99b39-63b8-a426-e053-dadaa90af4c2San-E-Pur ANTISEPTIC WIPES
77585-101-032022-01-28C16284748780-1d6a99b39-63b8-a426-e053-dadaa90af4c2San-E-Pur ANTISEPTIC WIPES
77585-101-042022-01-28C16284748780-1d6a99b39-63b8-a426-e053-dadaa90af4c2San-E-Pur ANTISEPTIC WIPES
77585-101-052022-01-28C16284748780-1d6a99b39-63b8-a426-e053-dadaa90af4c2San-E-Pur ANTISEPTIC WIPES
77585-101-112022-01-28C16284748780-1d6a99b39-63b8-a426-e053-dadaa90af4c2San-E-Pur ANTISEPTIC WIPES
77585-101-122022-01-28C16284748780-1d6a99b39-63b8-a426-e053-dadaa90af4c2San-E-Pur ANTISEPTIC WIPES
77585-101-132022-01-28C16284748780-1d6a99b39-63b8-a426-e053-dadaa90af4c2San-E-Pur ANTISEPTIC WIPES
77585-101-142022-01-28C16284748780-1d6a99b39-63b8-a426-e053-dadaa90af4c2San-E-Pur ANTISEPTIC WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77585-101-01San-E-Pur ANTISEPTIC WIPES2.17 mL in 1 PACKAGECLOTH2.172
77585-101-01San-E-Pur ANTISEPTIC WIPES1 in 1 POUCHCLOTH12
77585-101-02San-E-Pur ANTISEPTIC WIPES2.17 mL in 1 PACKAGECLOTH2.172
77585-101-02San-E-Pur ANTISEPTIC WIPES10 in 1 POUCHCLOTH102
77585-101-03San-E-Pur ANTISEPTIC WIPES30 in 1 POUCHCLOTH302
77585-101-03San-E-Pur ANTISEPTIC WIPES2.17 mL in 1 PACKAGECLOTH2.172
77585-101-04San-E-Pur ANTISEPTIC WIPES2.17 mL in 1 PACKAGECLOTH2.172
77585-101-04San-E-Pur ANTISEPTIC WIPES50 in 1 POUCHCLOTH502
77585-101-05San-E-Pur ANTISEPTIC WIPES80 in 1 POUCHCLOTH802
77585-101-05San-E-Pur ANTISEPTIC WIPES2.17 mL in 1 PACKAGECLOTH2.172
77585-101-11San-E-Pur ANTISEPTIC WIPES120 in 1 POUCHCLOTH1202
77585-101-11San-E-Pur ANTISEPTIC WIPES2.17 mL in 1 PACKAGECLOTH2.172
77585-101-12San-E-Pur ANTISEPTIC WIPES1200 in 1 BAGCLOTH12002
77585-101-12San-E-Pur ANTISEPTIC WIPES2.17 mL in 1 PACKAGECLOTH2.172
77585-101-13San-E-Pur ANTISEPTIC WIPES1200 in 1 BAGCLOTH12002
77585-101-13San-E-Pur ANTISEPTIC WIPES2.17 mL in 1 PACKAGECLOTH2.172
77585-101-14San-E-Pur ANTISEPTIC WIPES10 in 1 POUCHCLOTH102
77585-101-14San-E-Pur ANTISEPTIC WIPES10 in 1 PACKAGECLOTH102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77585-101SAN-E-PUR ANTISEPTIC WIPES (ETHYL ALCOHOL) CLOTH [ACOR FOODS-CSFTN LLC]2Legacy NDC, 18 package rows20201017_1e4205a9-e492-4e07-a171-6400b3495d7b.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
77585-10177585-101-01, 77585-101-02, 77585-101-03, 77585-101-04, 77585-101-05, 77585-101-14, 77585-101-11, 77585-101-12, 77585-101-13

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
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
GLYCERINPDC6A3C0OXIACT
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
b06412bb-f39e-4785-aeb6-86fb3842bc0f1e4205a9-e492-4e07-a171-6400b3495d7b2020-10-01WarningsExact identifier
spl id: b06412bb-f39e-4785-aeb6-86fb3842bc0f
spl set id: 1e4205a9-e492-4e07-a171-6400b3495d7b

Reported adverse events (FAERS/openFDA)#

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