FDA.reportPublic FDA data

Renew Periprotect

Manufacturer
DermaRite Industries, LLC
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:40:54

Label at a glance#

ProductRenew Periprotect
Active ingredientZINC OXIDE, DIMETHICONE
Label structure11 sections

Indications and uses

Helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness.

Dosage and administration

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.

Label contents#

Full prescribing information#

​Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

Dimethicone 1%

Purpose:

OTC - PURPOSE SECTION

Skin Protectant

Uses:

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash.
  • Protects minor skin irritation associated with

diaper rash and helps seal out wetness.

​Warnings:

WARNINGS SECTION

  • For external use only,
  • Avoid contact with eyes, In case of contact, flush thoroughly with water.

Warnings:

OTC - ASK DOCTOR SECTION

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.

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • 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:

OTHER SAFETY INFORMATION

  • Store at room temperature (59º-86ºF)
  • You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call 800-337-6296 Mon - Fri 9AM - 5PM EST.

Renew Periprotect Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Case LabelCase LabelPackage Label and Principal Display PanelPackage Label and Principal Display Panel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61924-435-042024-12-06C16284748780-11030e365-4e27-111a-e063-dadaa90a10e2Renew Periprotect
61924-435-042024-01-30C16284748780-11030e365-4e27-111a-e063-dadaa90a10e2Renew Periprotect

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61924-435-04Renew Periprotect114 g in 1 TUBEOINTMENT1144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61924-435RENEW PERIPROTECT (SKIN PROTECTANT) OINTMENT [DERMARITE INDUSTRIES, LLC]4Legacy NDC, 1 package rows20241208_5bd49bb0-03a7-562c-e053-2a91aa0a19d8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61924-43561924-435-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE92RU3N3Y1OACTIB
PETROLATUM4T6H12BN9UIACT
2-PHENYLPROPANAL PROPYLENE GLYCOL ACETAL1ZRR9A405AIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
TOCOPHERYL RETINOATE0WN694NBMMIACT
WATER059QF0KO0RIACT
N-(1,3,4-TRIS(HYDROXYMETHYL)-2,5-DIOXO-4-IMIDAZOLIDINYL)-N,N'-BIS(HYDROXYMETHYL)UREAENL2IA4WGWIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
CHOLECALCIFEROL1C6V77QF41IACT
ALOE VERA LEAF POLYSACCHARIDESW21O437517IACT
ALUMINUM STEARATEU6XF9NP8HMIACT
YELLOW WAX2ZA36H0S2VIACT
CORN OIL8470G57WFMIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLPARABENZ8IX2SC1OHIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
METHYLPARABENA2I8C7HI9TIACT
CHLOROXYLENOL0F32U78V2QIACT
LANOLIN7EV65EAW6HIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
288807b6-3f77-910e-e063-6394a90ac04d5bd49bb0-03a7-562c-e053-2a91aa0a19d82024-12-05WarningsExact identifier
spl id: 288807b6-3f77-910e-e063-6394a90ac04d
spl set id: 5bd49bb0-03a7-562c-e053-2a91aa0a19d8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.