NUMB520- lidocaine hydrochloride, phenylephrine hydrochloride spray

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 Ingredients

Lidocaine HCL 5%

Phenylephrine HCL, 0.25%

Purpose

Local Anesthetic

Vasoconstrictor

Uses:

For the temporary relief of local and anorectal itching, discomfort, and pain associated with anorectal disorders or anorectal inflammation.

Warnings

• for external use only.
• avoid contact with the eyes.

keep out of reach of children.

Do not use this product if

• pregnant or breastfeeding, ask a health professional before use.
• Tamper Evident "Do not use this product" if safety seal is broken or missing.
• you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of prostate gland unless directed by a doctor.

When using this product

• do not exceed the recommended daily usage.
• 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.
• if swallowed, call your Poison Control Center at 1(800) 222-1222.
• if condition worsens or does not improve within 7 days, consult a doctor.

Stop use and ask a doctor if

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

Directions

• clean the affected area.
• sensitivity and possible allergy tests advised prior to use. Spray spraingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs. You may reapply to continue numbing effect.
• apply to the affected area up to 4 times daily.
• children under 12 years 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

Allantoin, Arginine, Benzyl Alcohol, Disodium EDTA, Ethoxydiglycol, Phenoxyethanol, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Sulfite

Package Labeling:

INGREDIENTS AND APPEARANCE

NUMB520 
lidocaine hydrochloride, phenylephrine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63742-012
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 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ARGININE (UNII: 94ZLA3W45F)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM SULFITE (UNII: VTK01UQK3G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63742-012-00	72 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	05/01/2019

Labeler - Clinical Resolution Laboratory, Inc. (825047942)