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

LIDO5_55oz_label
(click image for full-size original)

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

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.