Label: ZINC OXIDE cream

  • 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, 2021

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  • Active ingredient

    Zinc Oxide-40%

  • Purpose

    Skin Protectant

  • Uses

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

    Do not use if quality seal is broken

    • Do not store above 104°F/40°C
  • Warnings

    For external use only

    • When using this product, do not get into eyes

    • Stop use and ask a 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
    • If swallowed, get medical help or contact a Poison Control Center right away
  • Directions

    Change wet and soiled diapers promptly

    • Cleanse the diaper area and allow to dry
    • Apply cream liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • INACTIVE INGREDIENT

    Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil*, Hydrogenated Palm Oil**, Theobroma Cacao (Cocoa) Seed Butter**, Cetyl Palmitate**, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Calophyllum Inophyllum Seed Oil, Tocopherol, Zea Mays (Corn) Starch*

    *Organic **RSPO Certified

  • Principal Display Panel – 118 mL Carton Label

    Skin Protectant

    hello
    bello™

    Made with sunflower seed,
    coconut, and tamanu oils

    Soothing Relief
    Zinc Oxide Treatment

    Diaper Rash
    Cream

    NET WT 4.0 fl. oz. (118ml) e

    • Hypoallergenic
    • Non-Nano Zinc Oxide
    • Pediatrician Tested
      Principal Display Panel – 118 mL Carton Label
  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73418-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide480 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sunflower Oil (UNII: 3W1JG795YI)  
    Castor Oil (UNII: D5340Y2I9G)  
    Hydrogenated Palm Oil (UNII: 257THB963H)  
    Cocoa butter (UNII: 512OYT1CRR)  
    Cetyl Palmitate (UNII: 5ZA2S6B08X)  
    Shea Butter (UNII: K49155WL9Y)  
    Coconut Oil (UNII: Q9L0O73W7L)  
    Tamanu oil (UNII: JT3LVK84A1)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73418-010-011 in 1 BOX02/01/2019
    1118 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:73418-010-021 in 1 BOX02/01/2019
    2236 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/2019
    Labeler - Unconditional Love d/b/a Hello Bello (081135707)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unconditional Love081135707MANUFACTURE(73418-010)
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