MedPath

Dr Tatty Numbing

Approved
Approval ID

5bb558c1-bf8f-4956-8732-e19720f62f31

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 17, 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 Code70171-0020
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lidocaine HCL
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 17, 2025
FDA Product Classification

INGREDIENTS (17)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ARNICA MONTANA FLOWERInactive
Code: OZ0E5Y15PZ
Classification: IACT
C13-14 ISOPARAFFINInactive
Code: E4F12ROE70
Classification: IACT
ELOSULFASE ALFAInactive
Code: ODJ69JZG85
Classification: IACT
DIMETHYL SULFONEInactive
Code: 9H4PO4Z4FT
Classification: IACT
EMU OILInactive
Code: 344821WD61
Classification: IACT
DIETHYLENE GLYCOL MONOETHYL ETHERInactive
Code: A1A1I8X02B
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
GLUCOSAMINE SULFATEInactive
Code: 1FW7WLR731
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
LAURETH-7Inactive
Code: Z95S6G8201
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE)Inactive
Code: 9FPL31B58Q
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TEA TREE OILInactive
Code: VIF565UC2G
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 4 g in 100 g
Code: V13007Z41A
Classification: ACTIR

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/17/2025

Product label

DR TATTY NUMBING CREAM LABEL.jpg

DR TATTY NUMBING CREAM LABEL.jpg

Dr Tatty Lido BOX.jpg

Dr Tatty Lido BOX.jpg

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 - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/31/2025

Active Ingredient

Lidocaine HCL 4%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/27/2025

Purpose

External Analgesic

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: 7/28/2025

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: 7/27/2025

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.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/27/2025

Questions?** 866-488-0066**

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.

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