Label: DIAPER RASH- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 18, 2023

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  • Active ingredient

    Zinc oxide 13%

  • Purpose

    Skin Protectant

  • Uses

    • helps treat and prevent daper rash
    • protects chafed skin due to diaper rash and helps seal out wetness
  • 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.

    If swallowed, get medial help or contact a Poison Control Center right away

  • Directions

    • change wet or soiled diapers promptly
    • cleanse the diaper area
    • allow to dry
    • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime whn exposure to wet diapers ay be prolonged
  • Other information

    store between 20° and 25°C (68° and 77°F)

  • Inactive ingredients

    water, mineral oil, petrolatum, beeswax, dimethicone, sorbitan sesquioleate, microcrystalline wax, PEG-30 dipolyhydroxystearate, Aloe barbadensis leaf juice, glycerin, tropolone, tocopheryl acetate, 1,2-hexanediol, caprylyl glycol, magnesium sulfate, potassium hydroxide, phenoxyethanol

  • SPL UNCLASSIFIED SECTION

    100%

    Satisfaction

    Guaranteed!

    (888) 309-9030

    DISTRIBUTED BY

    OLD EAST MAIN CO.

    100 Mission Ridge

    GOODLETTSVILLE, TN 37072

  • principal display panel

    Gentle Steps

    ZINC OXIDE

    DIAPER RASH CREAM

    SKIN PROTECTANT

    FREE FROM PARABENS, PHTHALATES & FRAGRANCES

    hypoallergenic

    pediatrician tested

    NET WT 4 OZ (133 g)

    image description

  • principal display panel

    DG baby Diaper Rash Cream

    Skin Protectant

    Zinc Oxide 13%

    Quaternium-15 & Paraben Free

    • Goes on smoothly
    • Helps heal, soothe and prevent diaper rash

    NET WT 4 OZ (113 g)

    image description

  • INGREDIENTS AND APPEARANCE
    DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-826
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE130 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-826-261 in 1 CARTON02/14/2012
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/14/2012
    Labeler - OLD EAST MAIN CO (068331990)
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