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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Drug Facts

Zinc Oxide  21.0%

Natural Skin Protectant

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.

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


       
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AVALON ORGANICS BABY PROTECTIVE ZINC DIAPER BALM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-1110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide21 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-1110-385 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/18/2011
Labeler - The Hain Celestial Group, Inc (858894996)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc858894996manufacture

Revised: 4/2012
Document Id: 78ffc894-e69c-4445-a32c-d271d7ceb8ed
Set id: 482114d3-793f-46b4-ae93-b278e0613d65
Version: 2
Effective Time: 20120430
 
The Hain Celestial Group, Inc