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NUMBING CREAMS

Approved
Approval ID

3b5e1a74-5946-4f1f-e063-6394a90a404b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 2, 2025

Manufacturers
FDA

Yongchun Lihui Trading Co., Ltd.

DUNS: 444053473

Products 1

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

Lidocaine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85881-001
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 2, 2025
FDA Product Classification

INGREDIENTS (11)

HORSE CHESTNUTInactive
Code: 3C18L6RJAZ
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LIDOCAINEActive
Quantity: 4 g in 100 g
Code: 98PI200987
Classification: ACTIB
CURCUMA LONGA (TURMERIC) ROOTInactive
Code: 856YO1Z64F
Classification: IACT
AQUAInactive
Code: 059QF0KO0R
Classification: IACT
ARNICA MONTANA FLOWERInactive
Code: OZ0E5Y15PZ
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
EMU OILInactive
Code: 344821WD61
Classification: IACT
HYDROGENATED SOYBEAN LECITHINInactive
Code: H1109Z9J4N
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/1/2025

labeling

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/1/2025

DirectionsClean the affected area with mild soap andwarm water, then rinse thoroughly andpat dry. For adults and children over 12 years old:Apply externally to the affected a-rea up to 4 timesa day. For children under 12 years: Consult adoctor before use.Using Finger Cots: Roll a fnger cot over your fnger.Apply a small amount of creamonto the fngertip.Evenly spread a thin layer of the cream over the skin.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/1/2025

Inactive Ingredients:Tocopheryl Acetate, Emu Oil, Propylene Glycol, Arica, Glycerin,MentholAesculus Hippocastanum (Horse Chestnut) Extract,Lecithin (Soybean),Curcuma Longa Extract, Aqua.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/1/2025

Safetyinformation Keep out of reach of children.if ingested, seek medical attention immediately. Do not use if you have allergiesto any of the ingredients.m if you are pregnant or breastfeeding consult a healthcareprovider before use.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/1/2025

Lidocaine 4%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/1/2025

Uses
For the temporary alleviation of localized discomfort,pruritus, pain, or burning sens.
ation in the perianal area associated withanorectal disorders.

WARNINGS SECTION

LOINC: 34071-1Updated: 8/1/2025

Warnings For external use only.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/1/2025

Discontinue use and consult a doctor if:Your condition worsens or does not improve within 7 days ou exper-ience anallergicreaction to any ingredient in this product.Symptoms persist, or redness.irritation, swellingor pain intensifes Symptoms improve but return after a few days.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/1/2025

Apply externally to the affected a-rea up to 4 timesa day

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NUMBING CREAMS - FDA Drug Approval Details