Active Ingredient
Zinc Oxide (3.8%)
Cmc Shield Skin Protectant
FDA Label NDC 71168-3066
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 Shield Skin Protectant (NDC 71168-3066). 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, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, 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
- temporarily protects from minor cuts, scrapes
- burns 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
Stop Use And Ask A Doctor If
Condition worsens or symptoms last more than 7 days or clear up and occur again in a few days, consult a physician
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Directions
- 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 anytime when exposure to wet diapers may be prolonged
- for poison ivy, oak, and sumac
- apply ointment liberally as needed
Other Information
- Store at a room temperature 15-30° C (59-86 F)
- Avoid excessive heat
Inactive Ingredients
aloe vera leaf, alpha-tocopherol, ceteth-10, cetostearyl alcohol, cetyl alcohol, cholecalciferol, glycerin, lanolin, lavender, methylparaben, mineral oil, paraffin, petrolatum, phenoxyethanol, polyethylene glycol 6000, polysorbate 60, propylparaben sodium, steareth-20, trolamine, vitamin-A, water, FDC Yellow No. 5, DC Red No.21
* Please review the disclaimer below.
