PRO NUMB- tattoo numbing spray spray

Pro Numb by

Drug Labeling and Warnings

Pro Numb by is a Otc medication manufactured, distributed, or labeled by Pro Numb Tattoo Numbing Spray LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Lidocaine HCI 5% Epinephrine HCI .01%

Purpose

Topical Anesthetic

Use

Temporarily takes away pain, itching, and swelling associated with anorectal disorders or pain-sensitive procedures.

Warnings

External Use Only. Keep out of reach of children.

Do not use if you have seizures or liver disease if pregnant or breastfeeding a known allergy or sensitivity occurs, discontinue use, and seek medical attention. If the condition intensifies or symptoms persist for more than seven days or clear up and occur again within a few days, Cease the use of this product and consult a doctor. Do not use in large quantities, Particularly over raw surfaces or blistered areas. Avoid contact with the eyes. If contact should occur, irrigate with large amounts of sterile saline and seek medical attention. Do not swallow, if swallowed, seek medical attention immediately.

When using this product, you may notice temporary whiting or redness of the skin where pro numb is applied.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Directions

A sensitivity test is encouraged before using. Spray a small amount on the broken area of the skin. Wait 60 seconds for the anesthetic to start working. Wash Pro Numb off completely before tattooing.

Other information

Store in a cool dark place or refrigerate and keep out of reach of children. Discard the item after the expiration date is due.

Inactive ingredients

purified RO water, Paraben-DU, Disodium EDTA, Citric acid, Optiphen.

QUESTIONS

Call: (800) 865-4965

Package Label - Principal Display Panel

120mL Spray NDC: 83389-111-11

INGREDIENTS AND APPEARANCE

PRO NUMB 
tattoo numbing spray spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83389-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE HYDROCHLORIDE	0.1 mg  in 100 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83389-111-11	120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/12/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/12/2023

Labeler - Pro Numb Tattoo Numbing Spray LLC (118964052)