Otc - Active Ingredient
Active ingredient PurposeZinc oxide 18%.........................Skin protectant
Zinc Oxide
FDA Label NDC 59779-083
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Zinc Oxide (NDC 59779-083). 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, indications & usage, warnings, dosage & administration, inactive ingredient, 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 chafed skin due to diaper rash andhelps seal out 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 right away.
Indications & Usage
Uses- helps prevent and treat diaper rash- protects chafed skin due to diaper rash and helps seal out wetness
Warnings
Warnings For external use only. _______________________________When using this product avoid contact with the eyes_______________________________Stop use and ask a doctor if condition worsensor does not improve after seven daysKeep out of reach of children. If swallowed getmedical help or contact a Poison Control Center right away.
Dosage & Administration
Directions- change wet and soiled diapers immediately- cleanse the diaper area and allow to dry- apply ointment liberally and as often as necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time such as bedtime._______________________________Other information- Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)- use with infants children and adults- will stain clothing and fabric
Inactive Ingredient
Inactive Ingredients castor oil, citric acid,mineral oil, paraffin, Peruvian balsam, petrolatum
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