FDA.reportPublic FDA data

San-E-Pur ANTISEPTIC WIPES

Manufacturer
Acor Foods-csftn Llc
Effective date
2020-10-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:31:49

Label at a glance#

ProductSan-E-Pur ANTISEPTIC WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

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.

DOSAGE & ADMINISTRATION SECTION

Directions • 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 SECTION

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

INACTIVE INGREDIENT SECTION

Inactive ingredients Disodium EDTA, Phenoxyethanol, Polysorbate 20, Sodium Hydroxide, Water

OTC - QUESTIONS SECTION

Questions?

+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

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 free-based
formula effectively reduces bacteria as well as serves as an antiseptic agent

Helps In Reducing Bacteria Safe for Skin 

KILLS GERMS

ALCOHOL FREE

Wipe Size

(5.9" x 7.8")
(15 cm x 20 cm) 

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.

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

www.san-e-pur.com

made in China

packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD2
1038558benzalkonium chloride 0.13 % Topical ClothSY2
1038558benzalkonium chloride 0.13 % Topical SwabSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77585-102-072022-01-28C16284748780-1d6a99b39-cb4e-a426-e053-dadaa90af4c2San-E-Pur ANTISEPTIC WIPES
77585-102-082022-01-28C16284748780-1d6a99b39-cb4e-a426-e053-dadaa90af4c2San-E-Pur ANTISEPTIC WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77585-102-07San-E-Pur ANTISEPTIC WIPES1200 in 1 CANISTERCLOTH12002
77585-102-07San-E-Pur ANTISEPTIC WIPES0.362 g in 1 PACKAGECLOTH0.3622
77585-102-08San-E-Pur ANTISEPTIC WIPES0.362 g in 1 PACKAGECLOTH0.3622
77585-102-08San-E-Pur ANTISEPTIC WIPES1200 in 1 CANISTERCLOTH12002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77585-102SAN-E-PUR ANTISEPTIC WIPES (BENZALKONIUM CHLORIDE) CLOTH [ACOR FOODS-CSFTN LLC]2Legacy NDC, 4 package rows20201017_c2d2d8a1-4b2f-4718-b008-3adc0e9cc9b0.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
77585-10277585-102-07, 77585-102-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM HYDROXIDE55X04QC32IIACT
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
f582e865-67cf-4fa8-9410-bfc5a1d5e59fc2d2d8a1-4b2f-4718-b008-3adc0e9cc9b02020-10-16WarningsExact identifier
spl id: f582e865-67cf-4fa8-9410-bfc5a1d5e59f
spl set id: c2d2d8a1-4b2f-4718-b008-3adc0e9cc9b0

Reported adverse events (FAERS/openFDA)#

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