FDA.reportPublic FDA data

Restoriden Lidocaine Cream

Manufacturer
RENU LABORATORIES, INC.
Effective date
2020-10-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:33:56

Label at a glance#

ProductRestoriden Lidocaine Cream
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure13 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Restoriden Nutrition LIDOCAINE PAIN RELIEF CREAM

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

OTC - PURPOSE SECTION

Purpose

Topical anesthetic

INDICATIONS & USAGE SECTION

Uses: to reduce pain or discomfort caused by skin irritations such as sunburn, insect bites, poison ivy, poison oak, poison sumac, and minor cuts, scratches or burns.

WARNINGS SECTION

For External Use only

OTC - WHEN USING SECTION

When using this product, do not use in or near the eyes

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

OTC - STOP USE SECTION

Stop Use and ask a doctor if:

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions: adults and children 2 years and older apply externally to the affected area up to 3 to 4 times a day

Children under 2 years, ask a doctor

OTHER SAFETY INFORMATION

May be applied under occlusive dressing

Store at 20 - 25° C

OTC - QUESTIONS SECTION

support@restoriden.com

INACTIVE INGREDIENT SECTION

Arnica Montana Extract, Capryl Glycol, Caprylic/Capric Triglycerides, Cetearyl Alcohol, Deionized Water, Emulsifying Wax NF, Ethylhexylglycerin, Glycerin,Hexylene Glycol, Hippophae Rhamnoides Fruit and Seed Oils, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Stearic Acid, Tetrasodium EDTA, Tocopherol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRODUCT LABEL

Jar LabelJar Label

AND PRODUCT BOX

Restoriden boxRestoriden box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010895lidocaine HCl 4 % Topical CreamPSN1
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCD1
1010895lidocaine hydrochloride 4 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-583-012022-01-28C16284748780-1d6a99b39-681a-a426-e053-dadaa90af4c2Restoriden Lidocaine Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-583-01Restoriden Lidocaine Cream1 in 1 BOXCREAM11
76348-583-02Restoriden Lidocaine Cream56 g in 1 JARCREAM561

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-583RESTORIDEN LIDOCAINE CREAM (LIDOCAINE) CREAM [RENU LABORATORIES, INC.]1Legacy NDC, 2 package rows20201120_b20e8649-9459-a9cb-e053-2a95a90ab31c.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
76348-58376348-583-02, 76348-583-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
HEXYLENE GLYCOLKEH0A3F75JIACT
HIPPOPHAE RHAMNOIDES SEED OILT53SBG6741IACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
PROPYLENE GLYCOL6DC9Q167V3IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
STEARIC ACID4ELV7Z65APIACT
TOCOPHEROLR0ZB2556P8IACT
POLYSORBATE 207T1F30V5YHIACT
HIPPOPHAE RHAMNOIDES FRUIT OILTA4JCF9S1JIACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE SODIUMMP1J8420LUIACT
WHITE WAX7G1J5DA97FIACT
JOJOBA OIL724GKU717MIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
b20e8649-945a-a9cb-e053-2a95a90ab31cb20e8649-9459-a9cb-e053-2a95a90ab31c2020-10-20WarningsExact identifier
spl id: b20e8649-945a-a9cb-e053-2a95a90ab31c
spl set id: b20e8649-9459-a9cb-e053-2a95a90ab31c

Reported adverse events (FAERS/openFDA)#

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