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Dr. Care Numbing Cream

Dr. Care Numbing Cream 30g/1.0 oz e

Approved
Approval ID

3e456af7-9726-d17e-e063-6394a90ab560

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 8, 2025

Manufacturers
FDA

Shengnan (Guangzhou) Cosmetics Co., LTD

DUNS: 541200425

Products 1

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

5% Lidocaine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84019-035
Application NumberM015
Product Classification
M
Marketing Category
C200263
G
Generic Name
5% Lidocaine
Product Specifications
Route of AdministrationRECTAL
Effective DateSeptember 8, 2025
FDA Product Classification

INGREDIENTS (6)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROXYACETOPHENONEInactive
Code: G1L3HT4CMH
Classification: IACT
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT
CARBOMERInactive
Code: 0A5MM307FC
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LIDOCAINEActive
Quantity: 100 mg in 1 g
Code: 98PI200987
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

1

INDICATIONS & USAGE SECTION

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

Temporary relief of
pain, itching, soreness,
or burning in the
perianal area from
anorectal disorders.

WARNINGS SECTION

LOINC: 34071-1Updated: 9/9/2025

For external use only.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/9/2025

Anorectal
(Hemorrhoidal)

OTC - STOP USE SECTION

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

Allergic reaction or
rectal bleeding occurs.
Redness, irritation,
swelling, or pain increases.
Condition worsens or
lasts >7 days

OTC - ACTIVE INGREDIENT SECTION

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

5% Lidocaine

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/9/2025

Do not exceed daily
dose unless directed
by a doctor.
Do not insert into
rectum using fingers
or devices.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/9/2025

Water, Aloe vera
extract, Vitamin E,
Propylene Glycol,
Carbomer, Glycerin,
Disodium Edta,
Hydroxyacetophenone,
1,2-Hexanediol, Mentha
Arvensis Leaf Extract,
Chrysanthellum Indicum
Extract, Portulaca
Oleracea Extract.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/9/2025

Adults and children 12
years and older: Apply a
thin layer to the affected
area 1-3 times daily or
as directed by a
healthcare provider.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/9/2025

Keep out of reach of
children. If swallowed,
get medical help or call
Poison Control.

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