Fresh Detox Antibacterial Wet Wipes
FDA Label NDC 79997-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aqua Kozmetik Dis Ticaret Anonim Sirketi for the product Fresh Detox Antibacterial Wet Wipes (NDC 79997-001). 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, when using this product, stop use and ask a doctor if, keep out of reach of 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

Antiseptic

Uses

  • wet 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 years of age
  • on open skin wounds
  • if you are allergic to any of the ingredients

When Using This Product

do not get into eyes. In case of contact, rinse eyes thoroughly with water for 15-20 minutes. Remove contact lenses, if present.

Stop Use And Ask A Doctor If

  • irritation and redness develop
  • condition persists for more than 72 hours

Keep Out Of Reach Of Children.

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

Directions

  • wet hands thoroughly with product and allow to dry without wiping
  • discard wipe in trash receptacle after use
  • supervise children under 6 years of age when using this product to avoid swallowing

Other Information

  • store between 15-30°C (59-86°F)
  • avoid freezing and excessive heat above 40°C (104°F)
  • may discolour certain fabric or surfaces

Inactive Ingredients

water, peg 7glyceryl cocoate, polysorbate 20, cocamidopropyl betaine, phenoxyethanol, dehydroacetic acid, benzoic acid, fragrance, edetate sodium, citric acid

Questions?

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[email protected]

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