Active Ingredients
Zinc Oxide 10%
Buttiezzz Intense
FDA Label NDC 70359-4102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fortunique B.v. for the product Buttiezzz Intense (NDC 70359-4102). 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 active ingredients, purpose, uses, warning, stop use and contact a doctor if, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
Helps treat and prevent diaper rash
Protect chafed skin due to diaper rash and helps seal out wetness
Warning
For external use only
Avoid contact with eyes
Stop Use And Contact A Doctor If
Condition worsens
Symptoms last more 7 days or clear up or occur within a few days
Not to be applied over deep or puncture wounds, infection or lacerations
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Directions
Change wet or soiled diapers promptly
Shake well before use. Make sure the thin is clean and dry before use. Use a sweeping movement to spray on the cream in a thin and uniform layer on the buttocks
Buttiezzz Intense is more effective when you apply a single thin layer. Use a spraying distance approximately 2 to 3 inches. It is not necessary to rub the cream. Apply Butiezzz Intense liberally as often as necessary or at every diaper change
Other Information
Store at room temperature bellow 77° F
Inactive Ingredients
Water(aqua)
Coco-Caprilate/Caprate
Glycerin
Alkyl-Alcohols
Alkyl Glucoside
Propilene Glycol
Cocoglycerides
Caprylyl glycol
Capryl Hydroxamic acid
Chamomilla Recutita(Matricaria)Flower Extract
Calendula Officinalis Flower Extract
Silica
Oleic Acid
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