Sanitex Antibacterial Hand Wipes Swab
FDA Label NDC 53118-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Precare Corp for the product Sanitex Antibacterial Hand Wipes (NDC 53118-002). 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 active ingredient, purpose, uses, warnings, do not use if, when using this product, stop use and ask a doctor, keep out of the reach children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzalkonium Chloride  0.13%


Purpose

Antimicrobial

Uses

  • For hand sanitizing to decrease bacteria on skin.
  • Recommended for repeated use.

Warnings

For external use only.

Do Not Use If

you are allergic to any of these ingredients.


When Using This Product

avoid contact with eyes. In case of eye contact, flush eyes with water.


Stop Use And Ask A Doctor

if irritation or redness develops, or if condition persists for more than 72 hours.


Keep Out Of The Reach Children.

If swallowed, get medical help or contact Poison Control Center right away.


Directions


   For  40 Count wipes:



  • Take wipe and rub thoroughly over all surfaces of both hands.
  • Rub hands together briskly to dry and allow to air dry.
  • Dispose of wipe in trash.
  • Do not flush.

    •   For 20 Count wipes:

                

                Adults and Children 2 Years and Over: Apply to hands and face. Allow to dry without wiping.

       

                Children Under 2 Years: Ask a doctor before use.



    • To Dispense:Peel back front label slowly. Remove Wipes.
      • To Reseal: Firmly run thumb over the label. Dispose of wipe in trash. Do not flush.

        •             


Other Information

  • Store below 95 F (35 C)
  • Keep closed tightly.
  • May discolor certain fabrics or surfaces.

Inactive Ingredients

Purified Water, SD Alcohol 40, Phenoxyethanol, Decyl Glucoside, Potassium Sorbate, Sodium Benzoate, Disodium EDTA, Citric Acid, Aloe Barbadensis (Aloe) Leaf Extract, Fragrance


Principal Display Panel

Sanitex®

Antibacterial

HAND WIPES

Kills 99.9% of Germs

Enriched with Aloe

FRESH SCENT

40 wipes| 5.6 inch x 7.5 inch (14.2 cm x 19.05 cm)





Sanitex®

Antibacterial

HAND WIPES

Kills 99.9% of Germs

Enriched with Aloe

FRESH SCENT

20 wipes| 5.6 inch x 7.5 inch (14.2 cm x 19.05 cm)





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