NDC | 71131-774-01 |
Set ID | 441c802f-a363-1530-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | UberScientific, LLC |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART346 |
- DRUG FACTS:
- Active Ingredient:
- Uses:
- Warnings:
- For external use only. Use only as directed.
Stop using this product if:
- Symptoms worsen or does not improve within seven days
- Bleeding occurs. Redness, irritation, swelling, pain or other symptoms develop.
- Directions:
- Adults and children 12-years and over: apply to affected area.
- Children under 12, consult a physician before use.
- How to Apply:
- Clean affected area with warm water nad mild soap. Rinse thoroughly.
- Gently dry by patting with toilet tissue or soft cloth.
- Apply externally to area up to six times per day.
- Other Ingredients:
Allantoin, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Propylene Glycol, Sodium Polyacrylate, Tocopheryl Acetate (Vitamin E), Triethanolamine.
- Store at room temperature. Avoid direct sunlight
- Package Labeling:
- INGREDIENTS AND APPEARANCE
UBER NUMB TOPICAL ANESTHETIC
lidocaine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71131-774 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 g Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) WATER (UNII: 059QF0KO0R) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71131-774-01 28.35 g in 1 JAR; Type 0: Not a Combination Product 12/20/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 12/20/2016 Labeler - UberScientific, LLC (080459429)