Baby Diaper
FDA Label NDC 42643-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tellurian for the product Baby Diaper (NDC 42643-101). 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, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENTS

ZINC OXIDE, 10%

Otc - Purpose

PURPOSE

SKIN PROTECTANT

Indications & Usage

USE

  • HELPS TREAT AND PREVENT DIAPER RASH.
  • PROTECTS CHAPPED SKIN DUE TO DIAPER RASH AND HELPS PROTECT FROM WETNESS.

Warnings

WARNINGS

FOR EXTERNAL USE ONLY

Otc - When Using

WHEN USING THIS PRODUCT DO NOT GET INTO EYES.

Otc - Stop Use

STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER 7 DAYS.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, SEEK MEDICAL HELP OR CALL POISON CONTROL CENTER IMMEDIATELY.

Dosage & Administration

DIRECTIONS

  • CHANGE WET AND SOILED DIAPER IMMEDIATELY
  • CLEANSE THE DIAPER AREA AND ALLOW SKIN TO DRY.
  • APPLY OINTMENT LIBERALLY AND AS OFTEN AS NECESSARY WITH EACH DIAPER CHANGE, ESPECIALLY WHEN EXPOSED TO WET DIAPERS FOR A PROLONGED PERIOD OF TIME, SUCH AS BEDTIME.

Inactive Ingredient

Inactive Ingredients: Water, Ethylhexyl Palmitate, Ricinus Communis (Castor) Seed Oil, Polyglycerin-6 Polyricinoleate, Polyglyceryl-10 Hexaoleate, Glycerin, Dimethicone, Sodium PCA, Ceramide 2, Ceramide 3, Ceramide 6lf, Aloe Barbadensis Leaf Juice, Hyaluronic Acid, Macadamia Ternifolia Seed Oil, Vegetable Oil, Camellia Saliva Seed Oil, Phytostearyl Canola Glycerides, Chamomilla Recutita (Matricaria) Extract, Panthenol (Vitamin B5), Tocopheryl Linoleate, Hydrogenated Coco-Glycerides, Myristyl Myristate, Sorbitan Laurate, Sodium Chloride, Zinc Sulfate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Sodium Benzoate, Potassium Sorbate.

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