Avalon Organics Baby Protective Zinc Diaper Balm
FDA Label NDC 61995-1110

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Hain Celestial Group, Inc for the product Avalon Organics Baby Protective Zinc Diaper Balm (NDC 61995-1110). 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 - keep out of reach of children, dosage & administration, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Zinc Oxide  21.0%

Otc - Purpose

Natural Skin Protectant

Indications & Usage

  • Helps treat and prevent diaper rash.
  • Protects chafed skin associated with diaper rash.
  • Helps protect against wetness

Warnings

When using this product keep out of eyes. Rinse with water to remove. Stop use and ask doctor if rash or irritation develops and lasts.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed get medical help or contact Poison Center right away.

Dosage & Administration

  • Apply liberally to clean,dry skin. Use as needed with diaper changes, especially at bedtime when exposure to wetness may be prolonged.

Inactive Ingredient

Helianthus Annuus (Sunflower) Seed Oil *, Glyceryl  Dibehenate, Tribehenin, Beeswax*, Carthamus Tinctorius (Safflower) Oil* , Olea Europea (Olive) Fruit Oil *, Simmondsia Chinensis (Jojoba) Seed Oil*, Aloe Barbadensis Leaf Juice* , Calendula Officinalis Flower Extract* , Chamomilla Recutita (Matricaria) Flower Extract *, Glycerin *, Glyceryl Behenate, Retinyl Palmitate, Tocopheryl Acetate.

* Certified Organic Ingredients

Otc - Questions

Questions? Visit  www.avalonorganics.com or call 888-659-7730

Package Label.Principal Display Panel


                       

* Please review the disclaimer below.