Label: ENGLEWOOD AMENITY- benzalkonium chloride and sodium monofluorophosphate kit

  • NDC Code(s): 42555-060-45, 59448-002-01, 59448-400-00
  • Packager: ASP Global, LLc
  • Category: HUMAN OTC DRUG LABEL

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 December 14, 2022

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  • SPL UNCLASSIFIED SECTION

    Instant Hand Antiseptic

    Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.095%

  • Purpose

    Antiseptic

  • Uses

    To help reduce bacteria on hands.

  • Warnings

    For external use only.

    When using this product avoid contact with eyes and lips. If contact occurs, rinse with water.

    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

    Rub dime sized amount between hands until dry.

    Children under 6 years of age should be supervised when using this product.

  • Inactive Ingredients

    Glycerin, Methylisothiazolinone, Propylene Glycol, Polyquaternium-37, Triethanolamine. Water

  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    Colgate® Anticavity Toothpaste

    Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76% (0.15%) w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    helps protect against cavities

  • Warnings

    Keep out of the reach of children under 6 years of age.

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
    children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
    children under 2 yearsask a dentist or physician
  • Inactive ingredients

    dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

  • Questions or comments?

    Call toll-free 1-800-468-6502

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    COLGATE-PALMOLIVE (THAILAND) Limited, Chonburi 20000, Thailand.

  • PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label

    ENGLEWOOD
    HEALTH

    Instant Hand Antiseptic

    Alcohol & Fragrance Free

    1.9 FL OZ / 53 mL

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

    Rev 04

    PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label
  • PRINCIPAL DISPLAY PANEL - 10 g Tube Label

    PT505037

    Colgate®
    Anticavity Toothpaste

    Cavity
    Protection

    NET WT 10g

    7
    OTHER

    PRINCIPAL DISPLAY PANEL - 10 g Tube Label
  • PRINCIPAL DISPLAY PANEL - Kit Label

    ENGLEWOOD
    HEALTH

    Contents/Origins:

    2.0 fl.oz. G&S Shampoo/Conditioner
    2.0 fl.oz. G&S Body Wash
    2.0 fl.oz. G&S Body Lotion
    2.0 fl.oz. Alcohol-Free Mouthwash
    0.15 oz. net wt. Lip Balm
    0.1 oz. G&S Deodorant
    1.9 fl.oz. Alcohol-Free Hand Sanitizer
    Toothbrush Case, Toothbrush, Hairbrush, Nail File, Eye Mask,
    Ear Plugs, Ear Phones, and Kit Case: Made in China
    Toothpaste: Made in Thailand

    Lot #: XMMDDFC Exp: YYYY-MM-DD

    Distributed by:
    ASP Global, LLC
    7800 Third Flag Parkway, Austell, GA 30168, USA
    REV 02

    ENGLEWOOD
    HEALTH

    Item #: ENGLWD1
    Description: Amenity Kit, Englewood

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

    Assembled in China

    Components Made in China:

    • Shampoo/Conditioner
    • Body Wash
    • Body Lotion
    • Alcohol-Free Mouthwash
    • Lip Balm
    • Deodorant
    • Alcohol-Free Hand Sanitizer
    • Toothbrush Case
    • Toothbrush
    • Hairbrush
    • Nail File,
    • Eye Mask,
    • Ear Plugs
    • Ear Phones
    • Kit Case

    Component Made in Thailand:

    • Toothpaste

    ENGLEWOOD
    HEALTH

    PRINCIPAL DISPLAY PANEL - Kit Label
  • INGREDIENTS AND APPEARANCE
    ENGLEWOOD AMENITY 
    benzalkonium chloride and sodium monofluorophosphate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59448-400
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59448-400-0020 in 1 BOX06/13/2018
    11 in 1 BAG
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 53 mL
    Part 21 TUBE 10 g
    Part 31 TUBE 59 mL
    Part 41 TUBE 59 mL
    Part 51 TUBE 59 mL
    Part 61 TUBE 4.25 g
    Part 71 BOTTLE, PLASTIC 65 mL
    Part 81 BOTTLE, WITH APPLICATOR 14 g
    Part 1 of 8
    INSTANT HAND ANTISEPTIC 
    benzalkonium chloride gel
    Product Information
    Item Code (Source)NDC:59448-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.095 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    POLYQUATERNIUM-37 (25000 MPA.S) (UNII: 31L31U8285)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59448-002-0153 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2018
    Part 2 of 8
    COLGATE ANTICAVITY 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Item Code (Source)NDC:42555-060
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    Water (UNII: 059QF0KO0R)  
    Sorbitol (UNII: 506T60A25R)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42555-060-4510 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/04/2009
    Part 3 of 8
    GILCHRIST AND SOAMES  BODY BUTTER
    cleansing (cold creams, cleansing lotions, liquids, and pads)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    INGRBENZYL ALCOHOL (UNII: LKG8494WBH)  
    INGRPEG-100 STEARATE (UNII: YD01N1999R)  
    INGRCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    INGRDEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    colorWHITEC48325
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    159 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic07/01/2013
    Part 4 of 8
    GILCHRIST AND SOAMES  HAIR 2 IN 1
    shampoos (non-coloring)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRSODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRCOCO MONOETHANOLAMIDE (UNII: C80684146D)  
    INGRPOLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 2600000 MW) (UNII: U1G23TFV1K)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRMAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    INGRMETHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    INGRMAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
    INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGRMETHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    INGRFD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Product Characteristics
    colorYELLOWC48330
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    159 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic07/01/2013
    Part 5 of 8
    GILCHRIST AND SOAMES  BODY REFRESHER--BODY WASH
    skin fresheners
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRSODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPOLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 2600000 MW) (UNII: U1G23TFV1K)  
    INGRCOCO MONOETHANOLAMIDE (UNII: C80684146D)  
    INGRMAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRMETHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    INGRMAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    INGRMETHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    INGRFD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    colorWHITEC48325
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    159 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic11/01/2016
    Part 6 of 8
    ENGLEWOOD  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
    colorYELLOWC48330
    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
    Cosmetic06/13/2018
    Part 7 of 8
    ENGLEWOOD  ALCOHOL-FREE
    mouthwashes and breath fresheners (liquids and sprays)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRMENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    INGRSACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    INGRCETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    colorBLUEC48333
    flavorMINTC73404
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    165 mL in 1 BOTTLE, PLASTIC ; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic06/13/2018
    Part 8 of 8
    GILCHRIST AND SOAMES   DEODORANT
    deodorants (underarm)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPOLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRWHITE WAX (UNII: 7G1J5DA97F)  
    INGRSTARCH, RICE (UNII: 4DGK8B7I3S)  
    INGRLAVENDER OIL (UNII: ZBP1YXW0H8)  
    INGRTANNIC ACID (UNII: 28F9E0DJY6)  
    INGRSODIUM LACTATE (UNII: TU7HW0W0QT)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRBENZYL ALCOHOL (UNII: LKG8494WBH)  
    INGRCOUMARIN (UNII: A4VZ22K1WT)  
    INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    114 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic10/24/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/13/2018
    Labeler - ASP Global, LLc (080361159)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shengzhou Kingbird Travel Products Co., Ltd.560219293PACK(59448-400) , LABEL(59448-400)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive (Thailand) LTD672044552MANUFACTURE(59448-400)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygienic Products Inc.421280161MANUFACTURE(59448-400)
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