MedPath

Bravado Labs Numbing

Approved
Approval ID

8c43f5b5-b911-4a7a-b2d1-56a09c54b001

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 30, 2025

Manufacturers
FDA

Prodigy Media Inc

DUNS: 080011622

Products 1

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

Lidocaine HCL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70171-0400
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lidocaine HCL
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 30, 2025
FDA Product Classification

INGREDIENTS (14)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALOE BARBADENSIS LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GREEN TEA LEAFInactive
Code: W2ZU1RY8B0
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ETHOXYDIGLYCOLInactive
Code: A1A1I8X02B
Classification: IACT
COMFREYInactive
Code: D05HXK6R3G
Classification: IACT
METHYLISOTHIAZOLINONEInactive
Code: 229D0E1QFA
Classification: IACT
CHAMOMILEInactive
Code: FGL3685T2X
Classification: IACT
CALENDULA OFFICINALIS FLOWERInactive
Code: P0M7O4Y7YD
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
TRIETHANOLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 5 g in 100 g
Code: V13007Z41A
Classification: ACTIR

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/30/2025

Product label

Bravado Labs Numbing Spray LABEL

Bravado Labs Numbing Spray LABEL Bravado Labs Numbing Spray BOX

Bravado Labs Numbing Spray BOX

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/28/2025

Uses

For the temporary relief of pain and itching associated with sunburns, minor cuts, insect bites, and skin irritations

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/30/2025

Purpose

External Analgesic

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/27/2025

Inactive ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract,C13-14 Isoparaffin, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Emu Oil,
Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid,Tea Tree Oil, Triethanolamine.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/30/2025

Questions?** 866-488-0066**

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/30/2025

Active Ingredient

Lidocaine HCL 5%

WARNINGS SECTION

LOINC: 34071-1Updated: 7/27/2025

Warnings

*For external use only. *Avoid contact with eyes

Stop use and ask a doctor if

  • Condition worsens or symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
  • Do not use in large quantities, particularly over raw surfaces or blistered areas. Do not exceed the recommended daily dosage unless directed by a doctor.

Do not use

  • On wounds or damaged skin.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/30/2025

Keep out of reach of children

If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/30/2025

Direction

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a physician.

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Bravado Labs Numbing - FDA Drug Approval Details