Zinc Oxide And Dimethicone
FDA Label NDC 50382-012

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Galentic Pharma (india) Private Limited for the product Zinc Oxide And Dimethicone (NDC 50382-012). 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 otc - active ingredient, purpose:, warnings:, dosage and administration:, other information, inactive ingredients, stop use if, indications and usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient        Purpose
Zinc Oxide (200 mg)      Diaper Rash
Dimethicone 1.8%         Skin Protectant

Purpose:

  • Helps treat and prevent diaper rash.
  • Dries the oozing and weeping of
  • poison ivy
  • poison oak
  • poison sumac

Warnings:

For external use only

Dosage And Administration:

For diaper rash

  • change wet and soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • Apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

    • For poison ivy, oak and sumac

    • apply ointment liberally as often as needed

Other Information

  • Do not use if seal is punctured or not visible
  • store at room temperature 15°-30° C (59°-86° F)
  • avoid excessive heat

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Cholecaliferol, Diazolidinyl Urea, Fragrance, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Purified Water, Retinyl Palmitate, Sodium Borate, Stearic Acid, Tocopheryl Acetate, Yellow 5, Yellow 6, Zea Mays (Corn) oil

Stop Use If

  • conditions worsen
  • symptoms last more than 7 days or clear up and occur in a few days, consult a physician
  • over large areas of the body
  • if you are allergic to these ingredients

Indications And Usage

Indications are for diaper rash and general skin protectant.

Do Not Use

  • deep or puncture wounds
  • animal bites
  • serious burns

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.

Principal Display Panel

GalShield with Dimethicone

GalShield D.jpg

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