Label: ANGEL OF MINE DIAPER RASH- zinc oxide ointment

  • 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 May 22, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc Oxide 16%

  • Purposes

    Skin Protectant

  • Uses

    • Helps treat and prevent diaper rash
    • Prevents chafed skin due to diaper rash
    • Helps seal out wetness
  • Warnings

    For external use only.

    When using this product

    • avoid contact wih eyes
    • this product contains chemicals, including lead, known to the State of California to case birth defects or othr reproductive harm 

    Stop use and ask a doctor if

    • Condition worsens
    • or does not improve within 7 days

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

  • Directions

    • Change wet or soiled diapers promptly
    • Clean the diaper area and allow to dry
    • Apply iubtnebt liberally as often as necessary, with each diaper change, especially at bedtime or any time prolonged exposure to wet diapers may be prolonged.
  • Inactive ingredients

    boric acid, castor ol, fragrance, microcrystalline wax, mineral oil, paraffin, petrolatum

  • PRINCIPAL DISPLAY PANEL

    Angel of mine™
    diaper rash Ointment 

    • Soothes the rash
    • Helps heal
    • Wipes of easily 

    Net Wt. 2 oz. (56g)

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    ANGEL OF MINE DIAPER RASH 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58638-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE160 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58638-002-0156 g in 1 TUBE; Type 0: Not a Combination Product05/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/22/2017
    Labeler - Wenzhou Senos Cosmetics Technology Co., Ltd. (420430722)
    Registrant - Wenzhou Senos Cosmetics Technology Co., Ltd. (420430722)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wenzhou Senos Cosmetics Technology Co., Ltd.420430722manufacture(58638-002)
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