NDC | 71131-050-04 |
Set ID | 65a319a6-89d2-44c9-81d5-30327f9948cb |
Category | HUMAN OTC DRUG LABEL |
Packager | UBERScientific, LLC |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- Drug Facts
- Active Ingredients
- Uses
External Use Only. Temporarily relieves pain, itching or swelling associated with anorectal disorders.
Close - Warnings:
Keep out of reach of children.
Do not use if pregnant or breast feeding. For external use only, if accidentally ingested, seek meical attention immediately. Do not use in large quantities, particularly over raw surfaces or blistered areas. Avoid contact with the eyes, if contact with the eyes occur, rinse with copious amounts of eyewash and seek medical attention immediately. Use on small area of skin to test for sensitivities prior to use.
Do not Use if:
- you have a history of seizures.
- you have been diagnosed with liver disease.
- you have an allergy to any of the ingredients listed. If a reaction or sensitivity occurs, discontinue use and seek medical attention immediately. If condition worsens or symptoms are persistent for more than five days, or recur after clearing up, consult with a medical professional immediately.
- Directions:
Prior to using therapeutically, test on small area of skin for sensitivities and possible allergies, if adverse reaction occurs seek medical attention. Spray UberNumb anesthetic spray, sparingly, on affected area. The Area should begin to feel numbing anestehetic relief within two minutes. For continued numbing releif, reapply UberNumb sparingly as needed.
Close
If at any point, irritations or other sensitivities occur, discontinue use and seek medical attention
Store in a cool dark place or refrigerate. Discard after expiration date - Inactive Ingredients:
Purified Water, Propylene Glycol, Sodium Metabisulfite, Citric Acid, Epinephrine HCL, Diazolidinyl Urea, Methyl Paraben, Propyl Paraben, and Disodium EDTA.
Close - Distributed by:
- Package Labeling:
- INGREDIENTS AND APPEARANCE
UBER NUMB
lidocaine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71131-050 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 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM METABISULFITE (UNII: 4VON5FNS3C) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71131-050-04 118.29 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/01/2017 Labeler - UBERScientific, LLC (080459429)