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  5. Label Information: Baby Diaper

FDA Label for Baby Diaper

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - WHEN USING
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DOSAGE & ADMINISTRATION
    9. INACTIVE INGREDIENT
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Baby Diaper Product Label

The following document was submitted to the FDA by the labeler of this product Tellurian. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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