Galentic Vitamin A D
FDA Label NDC 50382-003

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) Priva Te Limited for the product Galentic Vitamin A D (NDC 50382-003). 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:, when using this product:, stop use and ask a doctor if:, do not use:, keep out of reach of children, directions for diaper rash:, 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

White Petrolatum USP (76%)            Skin Protectant

Purpose:

  • Helps treat and prevent diaper rash
  • Helps seal out wetness
    • Temporarily protects minor * cuts * scrapes * burns
    • Temporarily helps protect and help relieve chapped and cracked skin and lips
    • Helps prevent and protect from the drying effects of wind and cold weather
    • Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash
    • With each diaper change, especially at bedtime when exposure to wet diapers may be prolonged

Warnings:

For External Use Only

When Using This Product:

  • Do not get in eyes

Stop Use And Ask A Doctor If:

  • If condition worsens
  • symptoms last more than 7 days or clear up and occur again in a few days

Do Not Use:

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.

Directions For Diaper Rash:

  • Change wet and soiled diapers promptly
  • Cleanse the diaper area and allow to dry
  • Apply as needed

Other Information:

  • Store at room temperature 15 deg C to 30 deg C    59 deg F to 86 deg F
  • Avoid excessive heat

Inactive Ingredients:

Inactive Ingredients: Light Liquid Parafin, Vitamin A, Vitamin D

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