LIDOCAINE NUMBING CREAM- lidocaine cream

Lidocaine Numbing Cream by

Drug Labeling and Warnings

Lidocaine Numbing Cream by is a Otc medication manufactured, distributed, or labeled by ONE2ZEE LIMITED LIABILITY COMPANY, YASH PHARMACEUTICALS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

Active Ingredient:

Lidocaine HCl 5.0%

Purpose

• External Analgesic

Uses:

For the temporary relief of pain and discomfort associated with anorectal disorders.

Warnings:

• For external use only. If condition worsens or does not improve within 7 days, consult a doctor.

When using this product,

• Do not exceed the recommended daily dosage unless directed by a doctor.
• In case of bleeding, consult a doctor promptly.
• Do not put this product into the rectum by using fingers or any mechanical device or applicator.
• Keep out of reach of children.
• If swallowed, get medical help or contact the Poison Control Center immediately.
• If pregnant or breast feeding, ask a health professional before use.

Directions:

Children under 12: Consult a doctor.

Adults and children 12 years and older: For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a clean, soft cloth before application of this product. Apply externally up to 6 times per day.

Keep out of reach of children.

Inactive Ingredients

Benzyl Alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine and Vitamin E Acetate

Other Information:

Store at room temperature. Avoid direct sunlight. Do not use if tamper evident packaging has been breached or is missing. See bottom of this jar for lot number and expiry date.

Distributed by: Wellspring Airmont, NY 10952 U.S.A.

Packaging label

INGREDIENTS AND APPEARANCE

LIDOCAINE NUMBING CREAM 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55629-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER 940 (UNII: 4Q93RCW27E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
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: 55629-050-01	113 mL in 1 JAR; Type 0: Not a Combination Product	04/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	04/24/2020

Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)

Registrant - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)

Establishment
Name	Address	ID/FEI	Business Operations
YASH PHARMACEUTICALS		871409551	manufacture(55629-050) , analysis(55629-050)