Active Ingredient
Zinc Oxide (20% w/w)
Cmc Zinc Oxide
FDA Label NDC 71168-3040
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Skylark Cmc Private Limited for the product Cmc Zinc Oxide (NDC 71168-3040). 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 ingredient, purpose, warnings, when using this product, stop use and ask 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
- helps treat and prevent diaper rash
- dries the oozing and weeping of poison ivy, poison oak, poison sumac
Warnings
For external use only
When Using This Product
- do not get into eyes
- do not use over large areas of the body
Stop Use And Ask A Doctor If
- if condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
- if you are allergic to any of these ingredients
Keep Out Of Reach Of Children
- if swallowed, get medical help or contact a Poison Control Center right away
Directions
- for diaper rash
- change wet and soiled diapers promptly
- cleanse the diaper area and allow to dry
- apply ointment liberally with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
- for poison ivy, oak, sumac
- apply ointment liberally as often as needed
Other Information
- store at 56°-86° F (15-30°C)
- avoid excessive heat
Inactive Ingredients
cetostearyl alcohol, cetomacrogol 1000, light liquid paraffin, white soft paraffin
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