Label: BABY MAGIC DIAPER RX - zinc oxide cream
- NDC Code(s): 45765-5130-0
- Packager: Naterra International INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- ACTIVE INGREDIENT
Active Ingredient : Zinc Oxide (28%)
Uses: Helps treat and prevent diaper rash , chaged skin and minor skin irritation by protecting and ealing out wetness.
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. In case of accidental ingestion, seek professional assistance or cntact a Poison Control Center right away
Warnings; For external use only
- INDICATIONS & USAGE
Change wet and soiled diapers promptly; cleanse diaper area and allow to dry
Apply product liberally with each diaper change and expecially at bedtime when exposure to wet diapers may be prolonged
- INACTIVE INGREDIENT
Allantoin ,Ascorbyl Palmitate , Beeswax , BHA , Carthamus Tintorius (Safflower) Seed Oil , Fragrance , Glycyrrhiza Glabra (Licorice) Root Extract ,
Persea Gratissima (Avocado) Oil , Petrolatum , Retinyl Palmitate , Tocopherol , Tocopheryl Acetate.
- DOSAGE & ADMINISTRATION
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- INGREDIENTS AND APPEARANCE
BABY MAGIC DIAPER RX
zinc oxide cream
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:45765-5130 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (Zinc Oxide ) Zinc Oxide 23.8 g in 85 g Inactive Ingredients Ingredient Name Strength Allantoin Ascorbyl Palmitate YELLOW WAX BUTYLATED HYDROXYANISOLE SAFFLOWER OIL GLYCYRRHIZA GLABRA AVOCADO OIL Petrolatum VITAMIN A PALMITATE Tocopherol Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45765-5130-0 85 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part347 04/30/2010 Labeler - Naterra International INC. (879056786)