PLUM SMOOTH PLUMB NUMB GELEE- lidocaine gel

Plum Smooth Plumb Numb Gelee by

Drug Labeling and Warnings

Plum Smooth Plumb Numb Gelee by is a Otc medication manufactured, distributed, or labeled by Universal Companies, Inc., Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

STOP USE

• skin becomes irritated
• condition worsens or symptoms last more than 7 days
• symptoms clear up and reoccur within a few days

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

INGREDIENTS AND APPEARANCE

PLUM SMOOTH PLUMB NUMB GELEE 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49911-884
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49911-884-01	28.35 g in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/29/2012

Labeler - Universal Companies, Inc. (127169782)

Establishment
Name	Address	ID/FEI	Business Operations
Filltech USA, LLC		926433855	manufacture(49911-884)