Update - 85569-003-01

Manufacturer: 100 KARMA INC
Effective date: 2026-08-12
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: daily-update
Hydrated at: 2026-08-15 01:00:52

Label at a glance#

ProductNumbing Cream

Active ingredientMENTHOL, LIDOCAINE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%
Menthol 0.7%

OTC - PURPOSE SECTION

Local Anesthetic

INDICATIONS & USAGE SECTION

For temporary relief local discomfort, itching, pain, soreness, or burning inthe perianal area associated with anorectal disorders and anorectal inflammation.

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use this product if

Pregnant or breastfeeding, ask a health professional before use.
If there is any allergic reaction to this product.
In case of accidental overdose, get medical help, or contact the poison control center immediately.

OTC - WHEN USING SECTION

Only take the recommended daily dosage unless otherwise instructed by a doctor.
Some individuals may experience allergic reactions to the ingredientscontained in this product.
Never put it into the rectum by using the finger or any medical device.

OTC - STOP USE SECTION

Stop using and ask a doctor

If discomfort persists for 7 days.
The symptoms being treated do not subside or if redness irritation swelling, pain, or other symptoms develop or increase.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Avoid contact with eyes.
In case of accidental ingestion, seek medical attention immediately.

DOSAGE & ADMINISTRATION SECTION

For adults: Cleanse the affected area with mild soap and warm water, and rinse thoroughly. Gently dry the area with toilet tissue or a soft cloth before applying the product.
Apply up to 4 times a day.
For children under 12 years of age: Consult a doctor.

OTHER SAFETY INFORMATION

Keep away from direct sunlight or heat.
Store at room temperature 59~-86°F(15°-30°C).

INACTIVE INGREDIENT SECTION

Water, Arnica, Emu Oil, Lecithin(Soybean), Propylene Glycol,Tocopheryl Acetate, Carbomer 934, Benzyl Alcohol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Numbing Cream

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0198168183373	GTIN-13: 0198168183373 EAN-13: 0198168183373 GTIN-12: 198168183373 UPC-A: 198168183373 GTIN storage (14 digits): 00198168183373	20250522165327.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

Numbing Cream
LIDOCAINE
MENTHOL
WATER
ALPHA-TOCOPHEROL ACETATE
CARBOMER 934
LECITHIN, SOYBEAN
BENZYL ALCOHOL
PROPYLENE GLYCOL
EMU OIL
ARNICA MONTANA FLOWER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
85569-003	85569-003-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MENTHOL	L7T10EIP3A	ACTIB
LIDOCAINE	98PI200987	ACTIB
WATER	059QF0KO0R	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
CARBOMER 934	Z135WT9208	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
EMU OIL	344821WD61	IACT
ARNICA MONTANA FLOWER	OZ0E5Y15PZ	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
1	2025-05-22	full-release	2026-06-01 01:02:52

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Numbing Cream	LIDOCAINE	100 KARMA INC	35b5ba9d-da1d-55d6-e063-6294a90a5fa8	2026-08-12	Warnings	Exact identifier ndc (package): 85569-003-01 ndc (product): 85569-003 ndc11 (package): 85569000301 spl id: 58db8e7d-8df2-dc6f-e063-6294a90a2ca0 spl set id: 35b5ba9d-da1d-55d6-e063-6294a90a5fa8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.