Pro Numb Tattoo Numbing Spray 120 Ml

Pro Numb Tattoo Numbing Spray 120 Ml
SPL v4
SPL
SPL Set ID f923860d-977a-c55f-e053-6294a90ae982
Route
TOPICAL
Published
Effective Date 2022-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Epinephrine (0.1 mg)
Inactive Ingredients
Citric Acid Monohydrate Water Edetate Disodium Propylparaben

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-04-12

Description

Lidocaine HCI 5% Epinephrine HCI .01%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine HCI 5% Epinephrine HCI .01%

Use

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

Section 50565-1

Keep out of reach of children.

Section 53413-1

Call: (800) 865-4965

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.

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.

Active Ingredient(s)

Lidocaine HCI 5% Epinephrine HCI .01%

Inactive Ingredients

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

Package Label Principal Display Panel

120mL Spray NDC: 83389-111-11


Structured Label Content

Use

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53413-1 (53413-1)

Call: (800) 865-4965

Purpose

Topical Anesthetic

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.

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 (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.

Active Ingredient(s)

Lidocaine HCI 5% Epinephrine HCI .01%

Inactive Ingredients (Inactive ingredients)

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

Package Label Principal Display Panel (Package Label - Principal Display Panel)

120mL Spray NDC: 83389-111-11


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)