PLUM SMOOTH PLUMB NUMB GELEE- lidocaine gel 
Universal Companies, Inc.

----------

Plum Smooth Plumb Numb Gelee

Active Ingredients

Lidocaine 4%

Purpose

Topical Anesthetic

Uses

For the temporary relief of discomfort and pain

Directions

Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily

Warnings

For external use only

Avoid contact with eyes

Do not use

In large quantities, particularly over raw surfaces or blistered areas

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Diazolidinyl Urea, Disodium EDTA, Glycerin, Menthol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, SD Alcohol 40-2, Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine

Distributed by:

Universal Companies, Inc. Abingdon, VA 24210

Plum Smooth Plumb Numb Gelee 1oz/28.35g

PlumSmoothLabel

PLUM SMOOTH PLUMB NUMB GELEE 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49911-884
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
COMFREY LEAF (UNII: DG4F8T839X)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49911-884-0128.35 g in 1 BOTTLE; Type 0: Not a Combination Product03/29/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01703/29/2012
Labeler - Universal Companies, Inc. (127169782)
Establishment
NameAddressID/FEIBusiness Operations
Filltech USA, LLC926433855manufacture(49911-884)

Revised: 11/2023
Document Id: 09c29a75-1493-1335-e063-6394a90a7f27
Set id: 6be7d8e0-6cd0-4da2-926f-3dbb3db3bd8e
Version: 3
Effective Time: 20231109
 
Universal Companies, Inc.