Drug Facts

AV3711001 AVALON ORGANICS BABY PROTECTIVE ZINC DIAPER BALM - zinc oxide cream
The Hain Celestial Group, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Zinc Oxide 21.0%

Natural Skin Protectant

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

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.

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

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

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

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

AV3711001 AVALON ORGANICS BABY PROTECTIVE ZINC DIAPER BALM
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61995-1110
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (Zinc Oxide)	Zinc Oxide	21 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL
TRIBEHENIN
WHITE WAX

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:61995-1110-3	85 g in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/18/2011

Labeler - The Hain Celestial Group, Inc (858894996)

Establishment
Name	Address	ID/FEI	Operations
The Hain Celestial Group, Inc		858894996	manufacture

Revised: 04/2012 The Hain Celestial Group, Inc