ADVANCED NUMB TOPICAL ANESTHETIC- lidocaine hydrochloride cream

ADVANCED NUMB Topical Anesthetic by

Drug Labeling and Warnings

ADVANCED NUMB Topical Anesthetic by is a Otc medication manufactured, distributed, or labeled by Uber Scientific, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Lidocaine HCL (5%)

Purpose

External Analgesic

Use

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.

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.

Directions

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.

Children under 12: Consult a Doctor.

Inactive ingredients

Allantoin Gel, Deionized Water, Benzyl Alcohol, Carbomer, Pro-pylene GLycol, Sodim Polyacrylate, Tocopheryl Acetate (Vitamin E), Triethanolamine

Other Information

Store at room temperature. Avoid Direct sunlight.

Package Labeling:

INGREDIENTS AND APPEARANCE

ADVANCED NUMB TOPICAL ANESTHETIC 
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71131-052
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71131-052-02	57 g in 1 JAR; Type 0: Not a Combination Product	04/20/2018
2	NDC: 71131-052-04	114 g in 1 JAR; Type 0: Not a Combination Product	04/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	04/20/2018

Labeler - Uber Scientific, LLC (080459429)