LIDOCAINE NUMBING CREAM- lidocaine cream 
ONE2ZEE LIMITED LIABILITY COMPANY

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.

----------

Lidocaine Numbing Cream topical anesthetic cream with vitamin E

DRUG FACTS:

Active Ingredient:

Lidocaine HCl 5.0%

Purpose

Uses:

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

Warnings:

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

4 oz label

LIDOCAINE NUMBING CREAM 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55629-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55629-050-01113 mL in 1 JAR; Type 0: Not a Combination Product04/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/24/2020
Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
Registrant - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
Establishment
NameAddressID/FEIBusiness Operations
YASH PHARMACEUTICALS871409551manufacture(55629-050) , analysis(55629-050)

Revised: 4/2020
Document Id: 3fdef3ae-192f-466e-a03b-468493562073
Set id: f54bcf70-0da8-49fe-8e25-0637ccacf038
Version: 1
Effective Time: 20200424
 
ONE2ZEE LIMITED LIABILITY COMPANY