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Calm and Correct Serum with Lidocaine

CALM and CORRECT PAIN RELIEF SERUM

Approved
Approval ID

ddcf1c2e-2f67-44d7-e053-2a95a90a812b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 9, 2025

Manufacturers
FDA

Renu Laboratories, LLC

DUNS: 119451815

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lidocaine 3 percent

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76348-725
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lidocaine 3 percent
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 9, 2025
FDA Product Classification

INGREDIENTS (10)

CYCLOMETHICONE 5Inactive
Code: 0THT5PCI0R
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
JOJOBA OILInactive
Code: 724GKU717M
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive
Code: 9E4CO0W6C5
Classification: IACT
ISOEUGENYL ACETATEInactive
Code: 9DF21GI8W6
Classification: IACT
SQUALANEInactive
Code: GW89575KF9
Classification: IACT
LIDOCAINEActive
Quantity: 1.5 g in 50 mL
Code: 98PI200987
Classification: ACTIB
DIHYDROEUGENOLInactive
Code: A3XE712277
Classification: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YI
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/2/2022

BOX ARTBOTTLE ART AND BOX ART

BOTTLE ART

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/2/2022

Uses

Temporarily relieves pain and itching due to

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/2/2022

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

LOINC: 50565-1Updated: 8/2/2022

Keep out of reach of children

If swallowed - get medical help or contact a poison control center right away

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/2/2022

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

LOINC: 51727-6Updated: 8/2/2022

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

LOINC: 60561-8Updated: 8/2/2022

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

Oklahoma City, OK 73112

www.dermamedics.com

1 800 990 6552

WARNINGS SECTION

LOINC: 34071-1Updated: 8/2/2022

Warnings

For external use only

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/2/2022

Active Ingredient

Lidocaine 3%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/2/2022

Purpose

External Analgesic

STATEMENT OF IDENTITY SECTION

LOINC: 69718-5Updated: 8/2/2022

DERMAMEDICS

Calm & Correct

Pain Relief

Serum with

3 % Lidocaine

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/2/2022

When using this product

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

Avoid contact with the eyes

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