INKEEZE ORIGINAL B NUMB CYLINDER- lidocaine gel 
Indelicare, LLC

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.

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Inkeeze Original Numb Professional Numbing Gel Cylinder

DRUG FACTS

ACTIVE INGREDIENTS:

Lidocaine 5%

PURPOSE:

Topical Anesthetic

USES:

External Use Only: For the temporary relief of local itching and discomfort in the perianal area.

INACTIVE INGREDIENTS:

Alcohol, Benzyl Alcohol Carbomer, Citric Acid, Ethoxydiglycol, Propylene Glycol, Purified Water.

DIRECTIONS:

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.

KEEP OUT OF REACH OF CHILDREN

If condition worsens or does not improve within 7 days, consult a doctor. 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. Certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

WHEN USING THIS PRODUCT:

you may notice temporary blanching or redness of the skin where gel is applied.

CONTACT:

1-800-611-7720 www.inkeeze.com

Package Labeling:

Label2

INKEEZE ORIGINAL B NUMB CYLINDER 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82022-001
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
ALCOHOL (UNII: 3K9958V90M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82022-001-0029.5 mL in 1 TUBE; Type 0: Not a Combination Product08/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34608/12/2021
Labeler - Indelicare, LLC (118075123)

Revised: 8/2021
Document Id: c95e45fb-e8fd-854e-e053-2a95a90aff98
Set id: c95e457a-cf67-9b8b-e053-2a95a90af90f
Version: 1
Effective Time: 20210812
 
Indelicare, LLC