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:

Label Label2

NUMB520
lidocaine liquid

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

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

Ingredient Name	Strength
Inactive Ingredients
CHOLESTEROL (UNII: 97C5T2UQ7J)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M015	05/15/2018

Labeler - Clinical Resolution Laboratory, Inc. (825047942)

Numb520 Spray