Label: BENSON BOTTOM PAINT- zinc oxide cream

  • NDC Code(s): 71706-060-02, 71706-060-06
  • Packager: Benson's Bottom Paint , Inc
  • 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 January 8, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Zinc Oxide 22%

  • Purpose

    Skin Protectant

  • Uses

    • To help promote healing of diaper rash
    • To help prevent diaper rash
    • Good for bedsores and blisters
  • Warnings

    For external use only

    When using this product

    • Do not get into eyes

    Stop use and ask a doctor if

    • Condition worsens
    • Symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children. In case of accidental ingestion contact a Poison Control Center immediately.

  • Directions

    • liberally apply Benson's Bottom Paint at first sign of redness or diaper rash daily until symptoms disappear.
    • apply after each change, especially at bedtime or whenever exposure to wet diapers may be prolonged
  • Other information

    • store at 20° to 30 ° C ( 68-86 °F)
    • may stain clothing
  • Inactive Ingredients

    Water, Petrolatum, Stearyl Alcohol, Paraffin, Glycerin, Polysorbate 60, Sorbitan steareate, Polysorbate 20, Cetyl Alcohol, Emulsifying Wax, NF, Aminomethyl Propanol, Quaternium-15

  • Questions?

    1-800-637-3882

  • SPL UNCLASSIFIED SECTION

    Distributed in the U.S. by:
    BENSON'S BOTTOM PAINT, INC.
    P.O. Box 1531 • Muskegon, MI 49443-1531

  • PRINCIPAL DISPLAY PANEL - 170.1 gram Tube Label

    Benson's
    Bottom Paint

    Soothes and Promotes Healing
    ™

    Pediatrician recommended
    Smooth, easy spreading
    No odor
    Isn't greasy
    Pharmacist formula

    net weight 6 ounces
    170.1 grams

    PRINCIPAL DISPLAY PANEL - 170.1 gram Tube Label
  • INGREDIENTS AND APPEARANCE
    BENSON BOTTOM PAINT 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71706-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Paraffin (UNII: I9O0E3H2ZE)  
    Sorbitan Monostearate (UNII: NVZ4I0H58X)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Polawax Polysorbate (UNII: Q504PL8E0V)  
    Quaternium-15 CIS-Form (UNII: LIT014L4RH)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71706-060-06170.1 g in 1 TUBE; Type 0: Not a Combination Product10/01/2017
    2NDC:71706-060-0256.7 g in 1 TUBE; Type 0: Not a Combination Product10/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34610/01/2017
    Labeler - Benson's Bottom Paint , Inc (018703513)
    Registrant - BMC 1092, Inc. dba Solo Laboratories, Inc (078831987)
    Establishment
    NameAddressID/FEIBusiness Operations
    BMC 1092, Inc. dba Solo Laboratories, Inc078831987MANUFACTURE(71706-060)
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