Pearls Antiseptic Wet Wipes Lavender
FDA Label NDC 79361-103

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Premier Brands Usa Llc for the product Pearls Antiseptic Wet Wipes Lavender (NDC 79361-103). 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 0.38%

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

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
  •  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

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

  • 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, dehydroaceer, peg 7glyceryl cocoate,
polysorbate 20, cocamidopropyl betaine, phenoxyethanol, dehydroacetic acid, benzoic acid, fragrance, edetate sodium, citric acid, chlorhexidine gluconate

Questions?

+1-954-993-9149
You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM

Other

PURE FRESH, PERFUMIC, ULTRA SOFT, TRUSTED

ANTIBACTERIAL PROTECTION

ALCOHOL FREE

NEUTRAL pH 5,5

Clean your Hand 

KEEP YOUR FAMILY HYGIENICALLY CLEAN

Fresh Pearls Wipes are the quick and easy way. Keep your family hygienically clean and protected at home away. They are ideal for instant clean ups of hands or face. Keep hands clean whether you are at home or in travelling.
Convenient for us in healthcare, nursing stations, patient bedside, long-term nursing care, the home, offices, car, restaurants, health clubs, workshops ... whenever soap and water are not available

Distributed By:

PREMIER BRANDS USA LLC

Pompano Beach, FL 33060

MADE IN TURKEY

DRY PLACE AWAY FROM DIRECT SUNLIGHT

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