ETADERM NUMBING CREAM- lidocaine cream

ETADERM Numbing Cream by

Drug Labeling and Warnings

ETADERM Numbing Cream by is a Otc medication manufactured, distributed, or labeled by NUEPHASE LLC, Bridgeview Investments LLC, Inspec Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine 5 %

Purpose

Local Anesthetic

Uses:

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

Warnings:

For external use only

When using this product

• ▪ 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

• ▪ 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.

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

If pregnant or breast-feeding, 

ask a health professional before use

Directions:

▪ 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.

Inactive Ingredients:

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

Questions?

424-354-4370

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ETADERM NUMBING CREAM 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84180-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER (UNII: 0A5MM307FC)
CHOLESTEROL (UNII: 97C5T2UQ7J)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84180-001-01	44 g in 1 TUBE; Type 0: Not a Combination Product	07/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/15/2022

Labeler - NUEPHASE LLC (118900101)

Registrant - Bridgeview Investments LLC (035014854)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC		081030372	manufacture(84180-001)