BED BUG INSTANT BITE RELIEF- lidocaine gel

Bed Bug Instant Bite Relief by

Drug Labeling and Warnings

Bed Bug Instant Bite Relief by is a Otc medication manufactured, distributed, or labeled by P.F. Harris Mfg. Co. LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

BED BUG INSTANT BITE RELIEF 
lidocaine gel

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/04/2016

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