Label: BAYLOR SCOTT AND WHITE HYBRID COMFORT- benzalkonium chloride kit

  • NDC Code(s): 59448-010-01, 59448-900-00
  • Packager: ASP Global, LLc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 17, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Benzalkonium chloride 0.13%

  • Purpose

    Antiseptic

  • Use

    for preparation of the skin prior to an injection.

  • Warnings

    For external use only. Flammable, keep away from fire or flame. Do not use with electrocautery procedures or near eyes. Stop use and ask a doctor if irritation or redness develops.

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

  • Directions

    Apply topically as needed to clean intended area. Discard after single use.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Disodium EDTA, DMDM Hydantoin, Ethylparaben, Methylparaben, Phenoxyethanol, Polysorbate 20, Sodium Citrate, Water

  • PRINCIPAL DISPLAY PANEL - Kit Label

    BaylorScott&White
    HEALTH

    Item #: BSWHYB01
    Description: KIT, BAYLOR SCOTT & WHITE HYBRID COMFORT

    PO #:
    Lot #: XMMDDFC
    Exp: YYYY-MM-DD
    Qty: 20 KIT/CS
    Carton #: XXX of XXX
    Net Wt.: XX.X KG
    Gross Wt.: XX.X KG
    Cubic Dimensions: XX x XX x XX CM

    Made in China

    Components:

    • Hand/Body Lotion
    • Lip Balm
    • Sleep Mask
    • Ear Plugs
    • Puzzle Book
    • Care Book
    • Door Hanger
    • Playing Cards
    • Pen
    • Hair Brush
    • Stress Ball
    • Hand Sanitizing Wipes
    • Kit Case

    For your comfort and healing, we hope to
    make your hospital experience as quiet and
    peaceful as possible. While it is not always
    feasible to stop all noise as we actively care
    for our patients, it is our priority to keep noise
    levels low, especially at night. If we are not
    meeting your expectations, please let us know.
    Thank you for trusting Baylor Scott & White
    with your care!

    BaylorScott&White
    HEALTH

    Contents/Origins:

    2.0 fl. oz. Hand/Body Lotion
    0.15 oz. net wt. Lip Balm
    Sleep Mask, Ear Plugs, Puzzle Book, Care Book, Door
    Hanger, Playing Cards, Pen, Hair Brush, Stress Ball,
    Hand Sanitizing Wipes, and Kit Case: Made in China

    Lot #:
    Exp:

    Distributed by:
    ASP Global, LLC
    7800 Third Flag Parkway, Austell, GA 30168, USA

    BaylorScott&White
    HEALTH

    REV 00

    BaylorScott&White
    HEALTH

    Principal Display Panel - Kit Label
  • PRINCIPAL DISPLAY PANEL - 6.2 g Applicator Label

    BaylorScott&White
    HEALTH

    OPEN

    Principal Display Panel - 6.2 g Applicator Label
  • INGREDIENTS AND APPEARANCE
    BAYLOR SCOTT AND WHITE HYBRID COMFORT 
    benzalkonium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59448-900
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59448-900-001 in 1 BAG03/15/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 APPLICATOR 6.2 g
    Part 21 TUBE 60 mL
    Part 31 TUBE 4.25 g
    Part 1 of 3
    BENZALKONIUM CHLORIDE 
    benzalkonium chloride cloth
    Product Information
    Item Code (Source)NDC:59448-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59448-010-0110 in 1 PACKAGE
    16.2 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/28/2022
    Part 2 of 3
    BAYLOR SCOTT WHITE   BODY
    cleansing (cold creams, cleansing lotions, liquids, and pads)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRMINERAL OIL (UNII: T5L8T28FGP)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPETROLATUM (UNII: 4T6H12BN9U)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRPEG-100 STEARATE (UNII: YD01N1999R)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRGLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    INGRHYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    INGRALLANTOIN (UNII: 344S277G0Z)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRCARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic03/15/2022
    Part 3 of 3
    ASP GLOBAL   LIP BALM
    lipstick
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRETHYLHEXYL PALMITATE (UNII: 2865993309)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRPOLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K)  
    INGRYELLOW WAX (UNII: 2ZA36H0S2V)  
    INGRHIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    INGRSHEANUT OIL (UNII: O88E196QRF)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Product Characteristics
    colorWHITEC48325
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14.25 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic11/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/15/2022
    Labeler - ASP Global, LLc (080361159)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shengzhou Kingbird Travel Products Co., Ltd.560219293PACK(59448-900)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!