Active Ingredient(S)
Lidocaine HCI 4.2% Epinephrine HCI .01%
Pro Numb Sensitive Skin Spray
FDA Label NDC 83389-112
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pro Numb Tattoo Numbing Spray Llc for the product Pro Numb Sensitive Skin (NDC 83389-112). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Anesthetic
Vasoconstriction
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.
Otc - 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.
Otc - Questions
Contact Pro Numb Distribution. (800) 865-4965
Package Label - Principal Display Panel
Label (Pronumb)
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