San-e-pur Antiseptic Wipes
FDA Label NDC 77585-102

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Acor Foods-csftn Llc for the product San-e-pur Antiseptic Wipes (NDC 77585-102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Otc - Active Ingredient

Active Ingredient

Benzalkonium Chloride 0.13%

Otc - Purpose

Purpose

Antiseptic

Indications & Usage

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

Warnings

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

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

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

Inactive Ingredient

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

Otc - Questions

Questions?

+1-901-212-1386

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

Other

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 on Skin And Surfaces

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

* Please review the disclaimer below.