Label: EARTHS BEST DIAPER RELIEF- zinc oxide ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-0405-4 - Packager: The Hain Celestial Group, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 22, 2012
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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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 - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EARTHS BEST DIAPER RELIEF
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-0405 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 21 g in 100 g Inactive Ingredients Ingredient Name Strength SUNFLOWER OIL (UNII: 3W1JG795YI) TRIBEHENIN (UNII: 8OC9U7TQZ0) WHITE WAX (UNII: 7G1J5DA97F) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) SAFFLOWER OIL (UNII: 65UEH262IS) OLIVE OIL (UNII: 6UYK2W1W1E) JOJOBA OIL (UNII: 724GKU717M) ALOE VERA LEAF (UNII: ZY81Z83H0X) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CHAMOMILE (UNII: FGL3685T2X) GLYCERIN (UNII: PDC6A3C0OX) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-0405-4 113 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 09/30/2011 Labeler - The Hain Celestial Group, Inc (858894996) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc 858894996 manufacture