Lidocaine Numbing Cream: Package Insert and Label Information

LIDOCAINE NUMBING CREAM- lidocaine cream
Yyba Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

LIDOCAINE NUMBING CREAM lidocaine cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73581-105 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (LIDOCAINE) LIDOCAINE 50 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL CARBOMER 940 CHOLESTEROL LECITHIN, SOYBEAN ISOPROPYL MYRISTATE POLYSORBATE 80 PROPYLENE GLYCOL WATER TROLAMINE .ALPHA.-TOCOPHEROL ACETATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73581-105-55 156 mL in 1 JAR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 06/17/2022

Labeler — Yyba Corp (006339772)

Registrant — Yyba Corp (006339772)

Establishment
Name	Address	ID/FEI	Operations
YASH PHARMACEUTICALS		871409551	manufacture (73581-105)

Revised: 06/2022 Yyba Corp