BABY MAGIC MEDICATED PATTY CAKE- zinc oxide cream

Baby Magic Medicated Patty Cake by

Drug Labeling and Warnings

Baby Magic Medicated Patty Cake by is a Otc medication manufactured, distributed, or labeled by Naterra International INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient : Zinc Oxide (28%)

PURPOSE

Uses: Helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps protect from wetness.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed ,get medical help or contact a  Poison Control Center immediately.

WARNINGS

Warnings; For external use only

INDICATIONS & USAGE

Direction

Change wet and soiled diapers promptly; cleanse diaper area and allow to dry

Apply product liberally as often as necessary, with each diaper change specially at bedtime or anytime when exposure to wet diapers may be prolonged. Swipe disposable cotton round applicator across Medicated Patty Cake.

Apply baby powder on baby's bottom and other areas that can use powder and are susceptible to irritating friction. For sanitation purpose, never touch a cotton round applicator that has been on the baby's bottom back  onto the powder.

Dispose of cotton round applicator after each use.

INACTIVE INGREDIENT

Allantoin ,Beeswax, Benzoic Acid, BHT, C12-15 Alkyl Benzoate, Copermicia Cerifera (Carnauba Wax) , Euphorbia Cerifera (Candellila) Wax, Fragrance , Glycereth-2 Cocoate , Hexyl Carprate , Lauryl Lysine , Nylon-12 , Ozokerite Wax, PEG-40  Stearate, Phenyl Trimethicone, Polymethylmethacrylate, Silica, Stearyl Alcohol, Titanium Dioxide, Tocopheryl  Acetate

PRINCIPAL DISPLAY PANEL

DOSAGE & ADMINISTRATION

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INGREDIENTS AND APPEARANCE

BABY MAGIC MEDICATED PATTY CAKE 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45765-5100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	2.75 g  in 11 g

Inactive Ingredients
Ingredient Name	Strength
Allantoin (UNII: 344S277G0Z)
Benzoic Acid (UNII: 8SKN0B0MIM)
YELLOW WAX (UNII: 2ZA36H0S2V)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
HEXYL DECANOATE (UNII: D2D42X538B)
LAUROYL LYSINE (UNII: 113171Q70B)
NYLON-12 (UNII: 446U8J075B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45765-5100-0	11 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	01/01/2012

Labeler - Naterra International INC. (879056786)