Drug Facts

Active Ingredients

Lidocaine 4%

Purpose

Topical Anesthetic

Uses:

For the temporary relief of discomfort and pain associated with • minor burns and skin irritations • minor cuts and scrapes • itching.

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 the eyes.

Do not use

in large quantities, particularly over raw or blistered areas.

Stop use and ask a doctor if

•skin becomes irritated • condition worsens or sysmptoms last than 7 days • symptoms clear up and recur 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

Package Labeling:

Outer Package Inner Package

BED BUG INSTANT BITE RELIEF
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70466-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CHAMOMILE (UNII: FGL3685T2X)
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)
COMFREY LEAF (UNII: DG4F8T839X)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70466-001-01	1 in 1 PACKAGE	02/04/2016
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	02/04/2016

Labeler - P.F. Harris Mfg. Co. LLC (829811798)

Bed Bug Instant Bite Relief Gel