FDA.reportPublic FDA data

Calm and Correct Serum with Lidocaine

Manufacturer
Renu Laboratories, LLC
Effective date
2025-05-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:00:54

Label at a glance#

ProductCalm and Correct Serum with Lidocaine
Active ingredientLIDOCAINE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Lidocaine 3%

OTC - PURPOSE SECTION

Purpose

External Analgesic

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves pain and itching due to

  • sunburn
  • minor burns
  • minor cuts
  • minor skin irritations

WARNINGS SECTION

Warnings

For external use only

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Condition gets worse
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again in a few days

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 to affected area not more than 3 to 4 times daily
  • children under 2 years of age : ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Cyclopentasiloxane, Dihydroeugenol, Dimethicone, Dimethiconol, Dimethicone/Vinyl Dimethicone Crosspolymer, Helianthus Annuus (Sunflower) Seed Oil, Isoeugenyl Acetate, Petrolatum, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane.

OTHER SAFETY INFORMATION

Manufactured in the U.S.A. for Dermamedics, LLC

Oklahoma City, OK 73112

www.dermamedics.com

1 800 990 6552

STATEMENT OF IDENTITY SECTION

DERMAMEDICS

Calm & Correct

Pain Relief

Serum with

3 % Lidocaine

OTC - WHEN USING SECTION

When using this product

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

Avoid contact with the eyes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOX ARTBOX ARTBOTTLE ART AND BOX ART

BOTTLE ARTBOTTLE ART

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2607527lidocaine 3 % Topical SolutionPSN2
2607527lidocaine 30 MG/ML Topical SolutionSCD2
2607527lidocaine 3 % Topical SolutionSY2

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-725-012025-05-12C16284748780-12cef2736-67f1-d83d-e063-dadaa90ab31fCALM and CORRECT PAIN RELIEF SERUM
76348-725-012025-01-30C16284748780-12cef2736-67f1-d83d-e063-dadaa90ab31fCALM and CORRECT PAIN RELIEF SERUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-725-01Calm and Correct Serum with Lidocaine1 in 1 BOXLIQUID12
76348-725-50Calm and Correct Serum with Lidocaine50 mL in 1 BOTTLE, PUMPLIQUID502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-725CALM AND CORRECT SERUM WITH LIDOCAINE (LIDOCAINE 3 PERCENT) LIQUID [RENU LABORATORIES, LLC]2Current NDC, Legacy NDC, 2 package rows20250514_ddcf1c2e-2f67-44d7-e053-2a95a90a812b.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-72576348-725-50, 76348-725-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYCLOMETHICONE 50THT5PCI0RIACT
PETROLATUM4T6H12BN9UIACT
JOJOBA OIL724GKU717MIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
ISOEUGENYL ACETATE9DF21GI8W6IACT
SQUALANEGW89575KF9IACT
LIDOCAINE98PI200987ACTIB
DIHYDROEUGENOLA3XE712277IACT
SUNFLOWER OIL3W1JG795YIIACT

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
Calm and Correct Serum with LidocaineLIDOCAINE 3 PERCENTRenu Laboratories, LLCddcf1c2e-2f67-44d7-e053-2a95a90a812b2025-05-09WarningsExact identifier
ndc (package): 76348-725-50
ndc (package): 76348-725-01
ndc (product): 76348-725
ndc11 (package): 76348072501
ndc11 (package): 76348072550
spl id: 34b77b18-b7e3-c3e3-e063-6294a90aead8
spl set id: ddcf1c2e-2f67-44d7-e053-2a95a90a812b

Reported adverse events (FAERS/openFDA)#

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