Active Ingredients:
Zinc Oxide 12%
Dimethicone 1%
Renew Periprotect
FDA Label NDC 61924-435
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dermarite Industries, Llc for the product Renew Periprotect (NDC 61924-435). 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:, warnings:, warnings:, directions:, other information:, inactive ingredients:, 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.
- Protects minor skin irritation associated with
diaper rash and helps seal out wetness.
Warnings:
- For external use only,
- Avoid contact with eyes, In case of contact, flush thoroughly with water.
Warnings:
Stop use and ask a doctor If
• condition worsens
• symptoms last more than 7 days or clear up and
occur again within a few days.
Keep out of reach of children.
In case of accidental ingestion contact a physician or Poison Control Center right away.
Directions:
- Change wet and soiled diapers promptly, cleanse the diaper area and allow to dry.
- Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Other Information:
- Store at room temperature (59°-86°F)
- You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047.
Inactive Ingredients:
Aloe Barbadensis Leaf Juice, Aluminum Stearate, Beeswax, Cholecalciferol, Chloroxylenol, Corn Oil, Imidazolidinyl Urea, Fragrance, Lanolin, Methylparaben, Mineral Oil, Paraffin Wax, Petrolatum, Phenoxyethanol, Propylene Glycol, Propylparaben, Retinyl Palmitate, Sorbitan Sesquioleate, Tocopheryl Acetate, Water.
Questions?
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