Label: HIPOGLOS- zinc oxide and lanolin ointment

  • 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 November 2, 2013

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  • Active ingredient

    Lanolin USP 15%

    Zinc Oxide 15%

  • Purpose

    Skin Protectant

  • Uses

    • Helps treat and prevent diaper rash.
    • Protects chafed skin due to diaper rash.
    • 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:

    • Conditions worsen.
    • Symptoms last more than 7 days or clear up and occur again within a few days.

    Do not use on:

    • Deep or puncture wounds
    • Animal Bites
    • Serious Burns

  • 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.
    • Allow to dry.
    • Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.
  • Other Information

    Store at 59° to 86° F (15 ° to 30° C)

  • Inactive ingredients

    Alcohol, Benzethonium Chloride, Cod Liver Oil (contains vitamin A and D), Lavender Fragrance, Mineral Oil, Petrolatum, Sorbitan Monostearate, Talc, Vanillin, and Water.

  • Propósito

    Protector dérmico

  • Usos

    • Ayuda a tratar y prevenir las irritaciones producidas por el pañal.
    • Protege la piel irritada debido a las rozaduras de pañal.
    • Ayuda a mantener la piel seca.
  • Warnings

    Para uso externo
    *Cuando use este producto no aplicar en los ojos.

    Descontinuar su uso y preguntar al médico si:
    • la condición empeora
    • Los síntomas permanecen por más de 7 días o si desaparecen y vuelven a aparecer luego de pocos días.

    No usar en:
    • Heridas profundas y punzantes.
    • Mordeduras de animales
    • Quemaduras graves

  • Mantener fuera del alcance de los niños

    * Si son ingeridos, consiga ayuda médica o acuda al Centro de Control de Envenenamiento inmediatamente.

  • Indicaciones de uso

    • Cambiar pañales mojados o sucios rápidamente.
    • Limpie la zona del pañal.
    • Deje secar.
    • Aplicar ungüento libremente de acuerdo a necesidad, con cada muda del pañal, especialmente a la hora de dormir o cuando la exposición a pañales mojados se prolongue más de lo habitual.
  • Otra información

    *Almacenar entre 59° y 86° F (15 y 30°C).

  • Excipientes

    alcohol, cloruro de bencetonio, aceite de hígado de bacalao (contiene vitaminas A y D), esencia de lavanda, aceite mineral, petrolato blanco, monoestearato de sorbitan, talco, vainillina, agua.

  • Principal Display Panel - Carton Label

    Carton Label

    Principal Display Panel - Carton Label

    Hipoglós® Ointment

    Helps prevent and treat diaper rash, skin irritation

    Net wt. 4.2 oz (120 g)

  • Principal Display Panel - Tube Label

    Principal Display Panel - Tube Label

    Tube Label

    Hipoglós® Ointment

    Helps prevent and treat diaper rash, skin irritation

    Net wt. 4.2 oz (120 g)

  • INGREDIENTS AND APPEARANCE
    HIPOGLOS 
    zinc oxide and lanolin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50145-222
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 g
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    TALC (UNII: 7SEV7J4R1U)  
    VANILLIN (UNII: CHI530446X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50145-222-011 in 1 CARTON
    1120 g in 1 TUBE
    2NDC:50145-222-021 in 1 CARTON
    2100 g in 1 TUBE
    3NDC:50145-222-031 in 1 CARTON
    372 g in 1 TUBE
    4NDC:50145-222-041 in 1 CARTON
    460 g in 1 TUBE
    5NDC:50145-222-051 in 1 CARTON
    55 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/03/2010
    Labeler - Laboratorios Andromaco S.A. (980106538)
    Registrant - Laboratorios Andromaco S.A. (980106538)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Andromaco S.A.980106538manufacture(50145-222)
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