D-COL PERSONAL HYGIENE CONVENIENCE KIT (PYRITHIONE ZINC AND CHLOROXYLENOL) KIT [D-COL INC]

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  • D-COL PERSONAL HYGIENE CONVENIENCE KIT (PYRITHIONE ZINC AND CHLOROXYLENOL) KIT [D-COL INC]

D-COL PERSONAL HYGIENE CONVENIENCE KIT (PYRITHIONE ZINC AND CHLOROXYLENOL) KIT [D-COL INC]
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NDC 53205-001-01
Set ID 273fcc6f-9c54-42b0-aa0c-9051457b1341
Category HUMAN OTC DRUG LABEL
Packager D-COL Inc
Generic Name
Product Class
Product Number
Application Number PART358H
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  • SPL UNCLASSIFIED SECTION

    D-COL Patient Antiseptic Skin Preparation

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Chloroxylenol 0.24%

  • Purpose

    Antiseptic

  • Uses

    • Antiseptic skin cleansers help reduce bacteria that potentially causes disease.
    • For patient antiseptic skin preparation (15 mL packets only).
    • For healthcare personnel hand wash.
    • For surgical hand scrub.
  • WARNINGS

    Do not use

    • If you or the patient is allergic to Chloroxylenol or any other ingredient in this product.

    When using this product

    • Keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums.
    • If contact occurs in any of these areas, rinse with cold water right away.
    • Repeated general cleansing of large body areas should not be done except when advised by a health care provider.

    Stop use and ask doctor if irritation, sensitization, or allergic reaction occurs.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Patient antiseptic skin preparation. Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product necessary to cover the skin area and wash gently. Rinse thoroughly with water.
    • Surgical hand scrub. Wet hands and forearms with water. Scrub for 3 minutes with about 5 mL of the product with a brush. Rinse thoroughly under running water.
    • Healthcare personnel handwash. Wet hands with water. Dispense about 5 mL of the product into cupped hands and wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.
  • Other Information

    • Store between 20-25°C (68-77°F).
    • Avoid excessive heat above 40°C (104°F).
  • Inactive Ingredient

    propylene glycol, cocamide dea, ammonium lauryl sulfate, sodium laureth sulfate, citric acid, edta, ammonium chloride, propylparaben, imidazolidinyl urea, fragrance, deionized water

  • SPL UNCLASSIFIED SECTION

    Net Wt. 15 mL per packet

  • SPL UNCLASSIFIED SECTION

    Distributed by: D-COL, Inc. 219 East Craig Place San Antonio, TX 78212

  • Questions?

    (210)-227-3612

  • SPL UNCLASSIFIED SECTION

    D-COL Nasal Inner Rim Cleanser

  • Uses

    For nasal inner rim cleanser.

  • Warnings

    For use only in the inner rim of each nostril.

    When using this product

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

    Stop use and ask doctor if irritation, discomfort, or redness develops.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply a reasonable amount of the product to the end of your index finger for a single nasal inner rim application.
    • Save a reasonable amount to apply to the opposite nasal inner rim.
    • Insert your index finger into one nostril no further than the inner rim, and cover the inner rim of the nasal passage with the product.
    • Do not apply the product beyond the inner rim of the nasal passage.
    • Repeat the application of the product to the untreated nasal inner rim.
    • Wait 30 seconds after you complete the application, and thoroughly wipe the inner rim of each nostril with a cloth wet with water.
    • Children under 6 years of age should be supervised when using this product.
  • Inactive Ingredient

    benzalkonium chloride, polysorbate 20, peach kernel oil glycereth-8 esters, sodium chloride, potassium sorbate, sodium citrate, xylitol, disodium edta, lavandula angustifolia (lavender) oil, mentha viridis (spearmint leaf) oil, melaleuca alternifolia (tea tree leaf) oil, citric acid

  • SPL UNCLASSIFIED SECTION

    Net Wt. 1 mL per packet

  • SPL UNCLASSIFIED SECTION

    Distributed by: D-COL, Inc. 219 East Craig Place San Antonio, TX 78212

  • Questions?

    (210)-227-3612

  • SPL UNCLASSIFIED SECTION

    D-COL Shampoo

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Zinc Pyrithione 1.0%

  • Purpose

    Anti-dandruff

  • Uses

    helps prevent recurrence of flaking and itching associated with dandruff.

  • Warnings

    For external use only.

    When using this product

    Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask doctor if condition worsens or does not improve after regular use of this product as directed.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product in your palm to thoroughly cover the scalp area.
    • Rub hands together until product covers entire surface of your palms.
    • Apply product to the scalp and thoroughly massage and cover the scalp.
    • Rinse with water until the product is completely removed from the application area.
    • Use one packet as directed.
    • Children under 6 years of age should be supervised when using this product.
  • Inactive Ingredient

    deionized water, acrylates/C10-30 alkyl acrylate crosspolymer, sodium lauryl ether sulfate, PEG-90 diisostearate, cocamidopropyl betaine, cocamide dea, cyclomethicone 5, edta sodium, caprylyl glycol, sodium hydroxide

  • SPL UNCLASSIFIED SECTION

    Net Wt. 7.4 mL per packet

  • SPL UNCLASSIFIED SECTION

    Distributed by: D-COL, Inc. 219 East Craig Place San Antonio, TX 78212

  • Questions?

    (210)-227-3612

  • PRINCIPAL DISPLAY PANEL - Kit Carton Label

    DCOL
    Personal Hygiene
    Convenience Kit

    Patient Antiseptic Skin Preparation
    Chloroxylenol .24%
    (3 count, Net Wt. 15 mL Per Packet)

    Shampoo
    Zinc Pyrithione 1.0%
    (3 count, Net Wt. 7.4 mL Per Packet)

    Nasal Inner Rim Cleanser
    Organic
    (1 count, Net Wt. 1 mL)

    Compare to active ingredient in Hibiclens: FDA:
    Chlorhexidine Gluconate can cause rare but serious life
    threatening allergic reaction.

    Single Use Packets

    PRINCIPAL DISPLAY PANEL - Kit Carton Label
  • INGREDIENTS AND APPEARANCE
    D-COL PERSONAL HYGIENE CONVENIENCE KIT 
    pyrithione zinc and chloroxylenol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53205-001
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53205-001-011 in 1 CARTON05/30/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 PACKET 22.2 mL
    Part 23 PACKET 45 mL
    Part 31 PACKET 1 mL
    Part 1 of 3
    D-COL 
    pyrithione zinc shampoo
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    PEG-90 Diisostearate (UNII: YAE61SLW68)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    17.4 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H05/30/2018
    Part 2 of 3
    D-COL PATIENT ANTISEPTIC SKIN PREPARATION 
    chloroxylenol soap
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q) Chloroxylenol2.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Propylene Glycol (UNII: 6DC9Q167V3)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    Ammonium Chloride (UNII: 01Q9PC255D)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    IMIDUREA (UNII: M629807ATL)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    115 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A05/30/2018
    Part 3 of 3
    D-COL NASAL INNER RIM CLEANSER 
    cleansing (cold creams, cleansing lotions, liquids, and pads) liquid
    Product Information
    Route of AdministrationNASAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRBenzalkonium Chloride (UNII: F5UM2KM3W7)  
    INGRPolysorbate 20 (UNII: 7T1F30V5YH)  
    INGRPeach Kernel Oil Glycereth-8 esters (UNII: RY37QKW66H)  
    INGRSodium Chloride (UNII: 451W47IQ8X)  
    INGRPotassium Sorbate (UNII: 1VPU26JZZ4)  
    INGRSODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    INGRXylitol (UNII: VCQ006KQ1E)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRLAVENDER OIL (UNII: ZBP1YXW0H8)  
    INGRSPEARMINT OIL (UNII: C3M81465G5)  
    INGRTEA TREE OIL (UNII: VIF565UC2G)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC05/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H05/30/2018
    Labeler - D-COL Inc (829947329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Identipak, Inc.942862350MANUFACTURE(53205-001) , LABEL(53205-001) , PACK(53205-001)
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