NDC 79361-102 Pearls Antiseptic Wet Wipes Lemon

Benzalkonium Chloride

NDC Product Code 79361-102

NDC 79361-102-08

Package Description: 80 PATCH in 1 PACKET > 4.59 g in 1 PATCH

NDC Product Information

Pearls Antiseptic Wet Wipes Lemon with NDC 79361-102 is a a human over the counter drug product labeled by Premier Brands Usa Llc. The generic name of Pearls Antiseptic Wet Wipes Lemon is benzalkonium chloride. The product's dosage form is patch and is administered via topical form.

Labeler Name: Premier Brands Usa Llc

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Pearls Antiseptic Wet Wipes Lemon Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BENZALKONIUM CHLORIDE .38 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Premier Brands Usa Llc
Labeler Code: 79361
FDA Application Number: part333A What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-30-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Pearls Antiseptic Wet Wipes Lemon Product Label Images

Pearls Antiseptic Wet Wipes Lemon Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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/flameFor external use onlyDo not usein children less than 2 months of ageon open skin woundsif you are allergic to any of the ingredientsWhen 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 ifirritation and redness developcondition 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 wipingdiscard wipe in trash receptacle after usesupervise 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

Questions?

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

Other

PURE FRESH, PERFUMIC, ULTRA SOFT, TRUSTEDANTIBACTERIAL PROTECTIONALCOHOL FREENEUTRAL pH 5,5Clean your Hand KEEP YOUR FAMILY HYGIENICALLY CLEANFresh 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 availableDistributed By:PREMIER BRANDS USA LLCPompano Beach, FL 33060MADE IN TURKEYDRY PLACE AWAY FROM DIRECT SUNLIGHT

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