Label: TENDER MOMENTS DELICATE BABY DIAPER RASH BALM- dimethicone,zinc oxide cream

  • NDC Code(s): 68828-700-01
  • Packager: Jafra Cosmetics International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 29, 2023

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  • Active Ingredients

    Dimethicone 2.0%, Zinc Oxide 10.0%

  • Purpose

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

  • KEEP OUT OF REACH OF CHILDREN

  • 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

  • Inactive Ingredients

    Water/Aqua, Petrolatum, Isopropyl Palmitate, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Ethylhexyl Stearate, Cetyl Dimethicone, Magnesium Sulfate, Beeswax/Cera Alba, Butyrospermum Parkii (Shea Butter), Panthenol, Butylene Glycol, Avena Sativa (Oat) Kernel Extract, DMDM Hydantoin, Glycine Soja (Soybean) Oil, Aloe Barbadensis Oil

  • Product label

    image description
  • INGREDIENTS AND APPEARANCE
    TENDER MOMENTS DELICATE BABY DIAPER RASH BALM 
    dimethicone,zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    OAT (UNII: Z6J799EAJK)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-700-011 in 1 CARTON12/29/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01612/29/2021
    Labeler - Jafra Cosmetics International, Inc. (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-700)
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