Abutol Antiseptic Wet Wipes
FDA Label NDC 78850-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fulya Kozmetik Islak Mendil Imalat Ve Pazarlama Limited Sirketi for the product Abutol Antiseptic Wet Wipes (NDC 78850-101). 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, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

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

Warnings

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.

Directions

  • open resealable label. Pull out wipes. Close resealable label to prevent drying out wipe hands thoroughly with product and allow to dry
  • dispose the wipe after use
  • supervise children under 6 years of age when using this product to avoid swallowing
  • do not flush

Other Information

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

Inactive Ingredients

benzoic acid, citric acid, cocamidopropyl betaine, dehydroacetic acid, fragrance, glycerin, PEG-7 glyceryl cocoate, phenoxyethanol, polysorbate 20, propylene glycol, tetrasodium EDTA, water, 

Other

PARIS
ANTISEPTIC AGENT

You may also report any serious side effects to

PO BOX 328, Wood Ridge, NJ 07075-328

Distributed By: American Brands and More LLC, Wood Ridge, NJ 07075

Packaging

Untitled (78850 101)

Untitled (78850 101)

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