Hipoglos
FDA Label NDC 50145-222

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratorios Andromaco S.a. for the product Hipoglos (NDC 50145-222). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

      • 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

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.

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)

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)

Principal Display Panel (Tube Label)

Tube Label

Hipoglós® Ointment

Helps prevent and treat diaper rash, skin irritation

Net wt. 4.2 oz (120 g)

* Please review the disclaimer below.