FDA Label for Diaper

View Indications, Usage & Precautions

Diaper Product Label

The following document was submitted to the FDA by the labeler of this product Medek Laboratories Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients                                                               Purpose

Zinc Oxide 12.8%..............................................................Skin Protectant


Purpose



Skin Protectant


Warnings



FOR EXTERNAL USE ONLY


When Using This Product



When using this product keep out of eyes.


Stop Use And Ask A Doctor If



Stop use and ask a doctor if condition worsens or does not improve after 7 days


Keep Out Of Reach Of Children



Keep out of reach of children.


Other Information



protect this product from excessive heat and direct sun


Inactive Ingredients



Petrolatum, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, camellia sinensis leaf extract, tocopheryl acetate, sunflower seed extract, sorbitan oleate, bisabolol, cholesterol


Indications



Uses

Help heal and prevent diaper rash

Protects chafed skin due to diaper rash and helps protect wetness


Do Not Use



Discontinue use if irritation occurs.


Ask A Doctor



Ask a doctor if condition worsens


Directions



change wet and soiled diapers promptly

cleanse the diaper area

allow to dry

apply ointment liberally as often as necessary with each diaper change and anytime when exposure to wet diapers may be prolonged


Dosage



apply ointment liberally as often as necessary with each diaper change and anytime when exposure to wet diapers may be prolonged


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