Label: BOOGIE BOTTOMS- dimethicone and zinc oxide spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 19, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Zinc Oxide 25%Skin Protectant
    Dimethicone 20%Skin Protectant
  • Uses

    • Helps treat and prevent diaper rash
    • Protects chafed skin due to diaper rash and helps seal out wetness.
  • Warnings

    • For external use only.

    • When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

    • Stop use and ask doctor if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days.

    • Keep out of reach of children.
    • Lock when not in use.
    • If swallowed, get medical help or contact a poison control center immediately.
  • Directions

    • Change wet and soiled diapers promptly.
    • Cleanse diaper area and allow to dry.
    • Shake bottle well before use. Unlock to spray.
    • Re-lock when not in use.
    • Spray 4-6 inches from skin. No rub-in is required.
    • Apply liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • Other Information

    Store at 59° F - 87° F

  • Inactive ingredients

    Cyclomethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Vitamin A Palmitate, Vitamin D3, White Petrolatum

  • Questions?

    1.877.469.8877 - MADE IN USA

  • SPL UNCLASSIFIED SECTION

    Distributed by Nehemiah Manufacturing Co,
    1907 South St, Cincinnati, OH U.S.A. 45204

  • PRINCIPAL DISPLAY PANEL - 49 ML Bottle Label

    NEW!
    NDC 75957-003-01

    Boogie
    BOTTOMS™

    No-Rub
    Diaper Rash Spray
    Skin Protectant

    SHAKE
    WELL

    Treats & Prevents diaper rash

    Spray-on application

    Fast & Easy to use

    25% Zinc Oxide

    Free from:
    fragrances • dyes • parabens

    NET 1.7 FL OZ (49ML)

    PRINCIPAL DISPLAY PANEL - 49 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    BOOGIE BOTTOMS 
    dimethicone and zinc oxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75957-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone200 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    CORN OIL (UNII: 8470G57WFM)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75957-003-0149 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2018
    2NDC:75957-003-023 in 1 CELLO PACK06/01/2018
    2NDC:75957-003-0149 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:75957-003-034 in 1 CELLO PACK06/01/2018
    3NDC:75957-003-0149 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:75957-003-041 in 1 BOX06/01/2018
    4NDC:75957-003-0149 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34706/01/2018
    Labeler - Nehemiah Manufacturing Company LLC (831701466)
    Establishment
    NameAddressID/FEIBusiness Operations
    Trividia Manufacturing Solutions, Inc.018927392MANUFACTURE(75957-003) , LABEL(75957-003) , PACK(75957-003)
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