Vitamin A D Ointment
FDA Label NDC 68786-213

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sion Biotext Medical Ltd. for the product Vitamin A D (NDC 68786-213). 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:, when using this product, stop use and ask a doctor if, do not use on, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

White Petrolatum USP (93% w/w)          

Purpose

Skin Protectant

Uses

  • 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 into eyes

Stop Use And Ask A Doctor If

  • The condition persists or gets worse
  • Symptoms last more than 7 days or clear up and occur again in a few days

Do Not Use On

  • Deep puncture or 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 and soiled diapers promptly
  • Cleanse the diaper area and allow to dry
  • Apply as needed

Other Information:

  • Store at controlled room temperature 150C to 300C (590- 860F)
  • Avoid excessive heat and humidity
  • Tamper Evident. Do not use if packet is torn, cut or open.

Inactive Ingredients

Lanolin, Light Liquid Paraffin, Vitamin A, Vitamin D

Principal Display Panel

NDC 68786-213-01

Vitamins A&D Ointment

Intensive Moisturizer for Skin Therapy

For Personal and Professional Use

SION MEDICAL

Made in Israel

144 Packets

Net Wt. 0.17oz(5g)

Label 1 (21301)

Label 1 (21301)

NDC 68786-213-02

Vitamins A&D Ointment

Intensive Moistuirzer for Skin Therapy

For Personal and Professional Use

SION MEDICAL

Made in Israel

4 tubes

Net Wt 4 oz (113 g)

Label 2 (21302)

Label 2 (21302)

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