Otc - Active Ingredient
Active Ingredient : Zinc Oxide (28%)
Baby Magic Medicated Patty Cake
FDA Label NDC 45765-5100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Naterra International Inc. for the product Baby Magic Medicated Patty Cake (NDC 45765-5100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, warnings, indications & usage, inactive ingredient, package label.principal display panel, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses: Helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps protect from wetness.
Otc - 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
Dosage & Administration
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