ETADERM Numbing Cream

Manufacturer: NUEPHASE LLC | Bridgeview Investments | Inspec Solutions LLC
Effective date: 2025-12-24
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:28:24

Label at a glance#

ProductETADERM Numbing Cream

Active ingredientLIDOCAINE

Label structure7 sections

Indications and uses

For temporary relief of local and Anorectal discomfort associated with Anorectal discomfort or inflammation

Dosage and administration

▪ Cleanse affected area and gently dry. Apply externally to the affected area up to 6 times daily, especially at night, in the morning or after each bowel movement ▪ Children under 12 years of age: consult a doctor.

Contacts and useful links#

PhoneLabel contact424-354-4370

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5 %

Purpose

OTC - PURPOSE SECTION

Local Anesthetic

Uses:

INDICATIONS & USAGE SECTION

For temporary relief of local and Anorectal discomfort associated with Anorectal discomfort or inflammation

Warnings:

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

▪ do not get into eyes. ▪ do not exceed the recommended daily dosage unless directed by a doctor ▪ do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if

OTC - STOP USE SECTION

▪ condition worsens or does not improve within 7 days. ▪ in case of bleeding, consult a doctor promptly ▪ Certain persons can develop
allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Directions:

DOSAGE & ADMINISTRATION SECTION

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, Vitamin E Acetate.

Questions?

OTC - QUESTIONS SECTION

424-354-4370

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1366789	lidocaine 5 % Rectal Cream	PSN	4
1366789	lidocaine 50 MG/ML Rectal Cream	SCD	4
1366789	lidocaine 5 % Rectal Cream	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LIDOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84180-001-01	ETADERM Numbing Cream	44 g in 1 TUBE	CREAM	44		4
84180-001-04	ETADERM Numbing Cream	113.4 g in 1 TUBE	CREAM	113.4		4

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

ETADERM Numbing Cream
Lidocaine
BENZYL ALCOHOL
CARBOMER
CHOLESTEROL
HYDROGENATED SOYBEAN LECITHIN
ISOPROPYL MYRISTATE
POLYSORBATE 80
PROPYLENE GLYCOL
WATER
TROLAMINE
.ALPHA.-TOCOPHEROL ACETATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
84180-001	84180-001-01, 84180-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZYL ALCOHOL	LKG8494WBH	IACT
CARBOMER	0A5MM307FC	IACT
CHOLESTEROL	97C5T2UQ7J	IACT
HYDROGENATED SOYBEAN LECITHIN	H1109Z9J4N	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
TROLAMINE	9O3K93S3TK	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
LIDOCAINE	98PI200987	ACTIB

Source Document#

Source XML

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
ETADERM Numbing Cream	LIDOCAINE	NUEPHASE LLC	5292c6ff-b878-4e71-878b-4bf08207612e	2025-12-24	Warnings	Exact identifier ndc (package): 84180-001-04 ndc (package): 84180-001-01 ndc (product): 84180-001 ndc11 (package): 84180000104 ndc11 (package): 84180000101 spl id: 46b82621-0092-2ac8-e063-6394a90a5e82 spl set id: 5292c6ff-b878-4e71-878b-4bf08207612e

Reported adverse events (FAERS/openFDA)#

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