EARTH BEST DIAPER RELIEF- zinc oxide ointment

Earth Best Diaper Relief by

Drug Labeling and Warnings

Earth Best Diaper Relief by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc, The Hain Celestial Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 19.0%

PURPOSE

Skin Protectant

INDICATIONS & USAGE

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

WARNINGS

For external use only. 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

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

DOSAGE & ADMINISTRATION

Change wet diaper promptly. Clean diaper area and allow to dry. Apply generously with each diaper change and before bedtime.

INACTIVE INGREDIENT

Helianthus Annuus (Sunflower) Seed Oil * ,Beeswax*, Glyceryl Dibehenate, Tribehenin, 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, Tocopheryl Acetate.

* Certified Organic Ingredients

QUESTIONS

Questions? Visit www.earthsbest.com or cal l877-527-6601

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EARTH BEST DIAPER RELIEF 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-4704
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
SAFFLOWER OIL (UNII: 65UEH262IS)
OLIVE OIL (UNII: 6UYK2W1W1E)
JOJOBA OIL (UNII: 724GKU717M)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
YELLOW WAX (UNII: 2ZA36H0S2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-4704-4	113 g in 1 TUBE; Type 0: Not a Combination Product	08/24/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/24/2011

Labeler - The Hain Celestial Group, Inc (117115556)

Registrant - The Hain Celestial Group, Inc. (014334364)

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc		117115556	manufacture(61995-4704)