FDA.reportPublic FDA data

DermaRad Relief

Manufacturer
RENU LABORATORIES, LLC
Effective date
2025-05-06
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:00:34

Label at a glance#

ProductDermaRad Relief
Active ingredientALLANTOIN, LIDOCAINE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Allantoin 1%

Lidocaine 4%

WARNINGS SECTION

Warnings

For External Use Only

Avoid contact with the eyes.

If condition worsens or if symptoms last more than

7 days or clear up and occur again within a few days,

discontinue use and consult a physician. Do not use on:

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

Do not use in large quantities, particularly over raw surfaces or blistered areas.

OTC - DO NOT USE SECTION

Do not use on:

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

Do not use in large quantities, particularly over raw surfaces or blistered areas.

OTC - PURPOSE SECTION

Purpose

Skin Protectant

Topical Analgesic

OTC - QUESTIONS SECTION

DermaMedics LLC, Oklahoma City, OK 73104

www.dermamedics.com

1-800-990-6552

DOSAGE & ADMINISTRATION SECTION

Directions: Adults and children 2 years of age and older,

apply to affected areas no more than 3 to 4 times daily.

For children under 2 years of age, consult your physician.

INDICATIONS & USAGE SECTION

Uses

  • For the temporary relief of pain and itching associated with minor burns, sunburn, or minor skin irritations.
  • Temporarily protects minor burns.
  • Temporarily protects and helps relieve chapped or cracked skin.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Capric/Caprylic Triglyceride, Capryl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Deionized Water, Dihydroeugenol,

Dimethicone, Dimethyl Isosorbide, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycol Stearate, Hexylene Glycol, Hydroxypropyl Starch Phosphate, Isoeugenyl Acetate, Niacinamide, PEG-100 Stearate, Petrolatum, Phenoxyethanol, Polyacrylate

Crosspolymer-6, PPG/SMDI Copolymer, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium PCA, Squalane, Stearic Acid, Tocopherol.

STATEMENT OF IDENTITY SECTION

DermaRad Relief

Topical Rehydrating Emulsion

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

DermaRad Relief Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DERMARAD LABEL AND OUTER BOX

DermaRad BoxDermaRad Box

2025 box2025 box

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-720-012025-05-07C16284748780-12cef2736-8a46-d83d-e063-dadaa90ab31fDermaRad Relief Topical Rehydrating Emulsion
76348-720-012025-01-30C16284748780-12cef2736-8a46-d83d-e063-dadaa90ab31fDermaRad Relief Topical Rehydrating Emulsion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-720-01DermaRad Relief1 in 1 BOXEMULSION17
76348-720-04DermaRad Relief118 mL in 1 TUBEEMULSION1187

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-720DERMARAD RELIEF (LIDOCAINE EMULSION) EMULSION [RENU LABORATORIES, LLC]7Current NDC, Legacy NDC, 2 package rows20250508_d5e11f73-918b-eeac-e053-2995a90a4a83.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-72076348-720-04, 76348-720-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALPHA-TOCOPHEROLH4N855PNZ1IACT
DIHYDROEUGENOLA3XE712277IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CETYL ALCOHOL936JST6JCNIACT
PPG-51/SMDI COPOLYMERKQ9JG3O3YAIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
NIACINAMIDE25X51I8RD4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARIC ACID4ELV7Z65APIACT
ALLANTOIN344S277G0ZACTIB
JOJOBA OIL724GKU717MIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE92RU3N3Y1OIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
GLYCOL STEARATE0324G66D0EIACT
ISOEUGENYL ACETATE9DF21GI8W6IACT
PEG-100 STEARATEYD01N1999RIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
GLYCERINPDC6A3C0OXIACT
EDETIC ACID9G34HU7RV0IACT
SODIUM HYDROXIDE55X04QC32IIACT
SQUALANEGW89575KF9IACT
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT)9M44R3409AIACT

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
DermaRad ReliefLIDOCAINE EMULSIONRENU LABORATORIES, LLCd5e11f73-918b-eeac-e053-2995a90a4a832025-05-06WarningsExact identifier
ndc (package): 76348-720-01
ndc (package): 76348-720-04
ndc (product): 76348-720
ndc11 (package): 76348072001
ndc11 (package): 76348072004
spl id: 347e1804-127a-52a4-e063-6394a90ad676
spl set id: d5e11f73-918b-eeac-e053-2995a90a4a83

Reported adverse events (FAERS/openFDA)#

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