NUMB520- lidocaine liquid

Numb520 by

Drug Labeling and Warnings

Numb520 by is a Otc medication manufactured, distributed, or labeled by Clinical Resolution Laboratory, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredient

Lidocaine 5%

Purpose

Local Anesthetic

Uses:

Temporarily relieves pain, itching, or swelling associated with anorectal disorders.

Warnings

(For external use only)

Do not use this product if

• Pregnant or breastfeeding, ask a health professional before use
• Tamper-evident shrink band around the container is broken.

When using this product

• Do not exceed the recommended daily unless directed by a doctor.
• Certain persons can develop allergic reactions to ingredients in this product.
• Do not put this product into the rectum by using fingers or any medical device or applicator.
• In case of accidental overdose, contact a doctor or Poison Control Center immediately. 

Stop use and ask a doctor if

The symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Keep out of reach of children

In case of accidental ingestion, seek medical attention immediately.

Directions

• Sensitivity test advised prior to use. Apply sparingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs (90 seconds). You may reapply to continue numbing effect.
• Apply up to 6 times a day.
• Children under 12 year of age: consult a doctor.

Other Information

• Keep away from direct sunlight or heat.
• Store in room temperature (59-86°F / 15-30°C).

Inactive Ingredients

Water, Aloe Barbadensis (Aloe Vera) Leaf Juice, Propylene Glycol, Benzyl Alcohol, Epinephrine HCL, Citric Acid, Disodium EDTA, Cholesterol, Sodium Metabisulfite, Lecithin, Polysorbate 80, Phenoxyethanol

Package Labeling:

INGREDIENTS AND APPEARANCE

NUMB520 
lidocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63742-006
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63742-006-00	123 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2018
2	NDC: 63742-006-01	251 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	05/15/2018

Labeler - Clinical Resolution Laboratory, Inc. (825047942)