MedPath

Numbnessspray

84938-003 Numbness Spray

Approved
Approval ID

3605fcbf-63c8-87b5-e063-6294a90a9c3e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 26, 2025

Manufacturers
FDA

Foshan Sugar Max Cosmetics CO.,Ltd

DUNS: 700689935

Products 1

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

Lidocaine

PRODUCT DETAILS

NDC Product Code84938-003
Application NumberM017
Marketing CategoryC200263
Route of AdministrationTOPICAL
Effective DateMay 26, 2025
Generic NameLidocaine

INGREDIENTS (10)

AQUAInactive
Code: 059QF0KO0R
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
SODIUM HYALURONATEInactive
Code: YSE9PPT4TH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
KOJIC ACIDInactive
Code: 6K23F1TT52
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
LIDOCAINEActive
Quantity: 0.04 g in 1 mL
Code: 98PI200987
Classification: ACTIB
TRISODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/26/2025

label2

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/26/2025

Temporarily relieves pain and itching due to: Tattoo procedures,
Minor scrapes, Minor cuts, Minor skin irritations,
Tattoo Laser Remova

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/26/2025

lf swallowed, get medical help or contact Poison Control at 1-800-222-1222.Store at room temperature and do not freeze

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/26/2025

Adults and children 12 years and older: Apply a generouslayerto the affected area 15-30 minutes before the procedure.Allow the anesthetic to take effect, For prolonged comfort,reapply as necessary, but do not exceed 3 applications in 24hours. Children under 12 years: Consult a doctor before use.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/26/2025

Aqua
Propylene Glycol
Sodium Hyaluronate
Kojic Acid
Sodium Hydroxide
Trisodium Citrate
1,3-Butanediol
Phenoxyethanol
Ethylhexylglycerin

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/26/2025

Keep out of reach of children.
Not foruse on children under 12 years old, consult a doctor beforeuse.
Avoid contact with eyes, mouth, or open wounds.
Do not apply over large areas of the body.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/26/2025

Stop use and seek medicaattention if irritation, rash, or an allergic reaction occurs, or ifsymptoms worsen or persist for more than seven days.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/26/2025

Lidocaine 4%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/26/2025

External Analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 5/26/2025

For external use only

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Numbnessspray - FDA Drug Approval Details