Label: DIMETHICONE AND 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 February 16, 2011

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  • ACTIVE INGREDIENT

    Active ingredients                       Purpose
    Dimethicone 1%........................Diaper rash cream
    Zinc Oxide 10%........................Diaper rash cream
  • PURPOSE

    Active ingredients                       Purpose
    Dimethicone 1%........................Diaper rash cream
    Zinc Oxide 10%........................Diaper rash cream
  • KEEP OUT OF REACH OF CHILDREN

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

    Uses
    - helps treat and prevent diaper rash
    - protects minor skin irritation due to diaper rash and
    helps seal out wetness
  • WARNINGS

    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 several days
  • DOSAGE & ADMINISTRATION

    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, especially at bedtime or anytime
    when exposure to wet diapers may be prolonged

    Other information
    Store between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)
  • INACTIVE INGREDIENT

    Inactive Ingredients aloe barbadensis extract,
    benzyl alcohol, coconut oil, cod liver oil (contains
    vitamin A and vitamin D), fragrance, glyceryl oleate, light
    mineral oil, ozokerite, paraffin, propylene glycol,
    sorbitol, synthetic beeswax, water


  • PRINCIPAL DISPLAY PANEL

    label
  • INGREDIENTS AND APPEARANCE
    DIMETHICONE AND ZINC OXIDE 
    dimethicone and zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-082
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    GLYCERYL MONOOLEATE (UNII: 4PC054V79P)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ALOE (UNII: V5VD430YW9)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-082-02113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2009
    Labeler - CVS (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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