Procure Vitamin A And D Ointment
FDA Label NDC 55681-215

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Twin Med, Llc for the product Procure Vitamin A And D (NDC 55681-215). 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 ingredients(in each gram), purpose, uses, warnings, when using this product, stop use and ask 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 Ingredients(In Each Gram)

White Petrolatum (USP 93.4% w/w)

Purpose

Skin Protectant

Uses

  • Helps treat and prevent diaper rash
  • Helps seal out wetness
  • Temporarily protects minor cuts, scrapes and burns
  • Temporarily helps protect and helps relieve chapped and cracked skin or 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

  • Avoid contact with eyes

Stop Use And Ask Doctor If

  • The condition persists or get worse
  • Symptoms last more than 7 days or clear up and occur again in 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 and soiled diapers promptly
  • Cleanse the diaper area, and allow to dry
  • Apply as needed

Other Information

  • Store at room temperature 150 - 300 c ( 590 - 860 F)
  • Avoid excessive heat and humidity
  • Tamper Evident
  • Do not use if packet it torn, cut or opened.

Inactive Ingredients

Lanolin, Light Liquid Paraffin, Vitamin A, and Vitamin D

Principal Display Panel

Procure

VITAMIN A AND D

OINTMENT

Skin Protectant

12

tubes

Each Tube

Net Weight: 4 ounces

Procure

VITAMIN A AND D

OINTMENT

Skin Protectant

144

PACKETS


Net Weight: 5 grams


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