MedPath

Numbness Cream

84938-002 Numbness Cream

Approved
Approval ID

3605961a-d596-9c4a-e063-6394a90a99dc

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 Code84938-002
Application NumberM017
Marketing CategoryC200263
Route of AdministrationTOPICAL
Effective DateMay 26, 2025
Generic NameLidocaine

INGREDIENTS (11)

ALOE BARBADENSIS LEAF JUICEInactive
Code: RUE8E6T4NB
Classification: IACT
TRIETHANOLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
CETEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
LIDOCAINEActive
Quantity: 0.04 g in 1 g
Code: 98PI200987
Classification: ACTIB
AQUAInactive
Code: 059QF0KO0R
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
COCOS NUCIFERA (COCONUT) OILInactive
Code: Q9L0O73W7L
Classification: IACT
BUTYROSPERMUM PARKII (SHEA) BUTTERInactive
Code: K49155WL9Y
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CARBOMERInactive
Code: 0A5MM307FC
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

label

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 Removal

OTC - STOP USE SECTION

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

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

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
Cetearyl Alcohol
Cocos Nucifera (Coconut) Oil
Butyrospermum Parkii (Shea) Butter
Glycerin
Aloe Barbadensis Leaf Juice
Carbomer
Triethanolamine
Phenoxyethanol
Ethylhexylglycerin

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.

OTC - WHEN USING SECTION

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

Not foruse on children under 12 years old, consult a doctor beforeuse.
Avoid contact with eyes, mouth, or open wounds.

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Numbness Cream - FDA Approval | MedPath