ALLERCAINE WITH BITTRAN II- lidocaine hydrochloride and benzalkonium chloride spray

Allercaine with Bittran II by

Drug Labeling and Warnings

Allercaine with Bittran II by is a Animal medication manufactured, distributed, or labeled by Tomlyn Products, a Division of Vetoquinol USA, Inc., Vetoquinol USA, Inc., Delta Synthetic Co., Ltd. , Tropichem Research Labs, LLC dba Vetio. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VETERINARY INDICATIONS

Hot Spot Spray by Tomlyn® is an antiseptic, anti-itch spray that calms, soothes and temporarily relieves pain and itching caused by insect bites and other minor allergic problems in dogs. It also helps prevent infection in minor cuts, scrapes and burns.

Hot Spot Spray with Bittran™ II (a safe, bitter substance that discourages animals from licking and biting irritated areas) can be used daily to help control compulsive scratching and spot chewing problems in dogs. Hot Spot Spray adheres easily to the skin (no messy run-off) and vanishes, leaving your dog's skin and coat dry and non-sticky.

DIRECTIONS:

Spray on localized irritated areas as required. Dogs who are highly allergic should be bathed regularly for optimal skin and tissue health.

PRECAUTIONS:

Consult your veterinarian immediately if swelling occurs, or if redness and irritation persist for five days or more. Avoid contact with eyes. Avoid excessive application. Do not apply to entire body or to large areas of broken skin. Wash hands after use.

FOR EXTERNAL ANIMAL USE ONLY.

DO NOT USE ON CATS.

KEEP OUT OF REACH OF CHILDREN AND PETS.

ACTIVE INGREDIENTS:

• Lidocaine hydrochloride: 2.4%
• Benzalkonium chloride: 0.1%

Compounded in a vanishing liquid base containing PEG-75 lanolin, aloe vera gel, allantoin and denatonium benzoate (Bittran™ II), among other ingredients. Stabilized at a pH of normal animal skin.

QUESTIONS?

Manufactured for:
Tomlyn® Products
Division of Vetoquinol USA, Inc.
Ft. Worth, TX (USA) 76137
1 (877) 580-7729
www.tomlyn.com

411388
14

SPL UNCLASSIFIED SECTION

100%
SATISFACTION
GUARANTEED!

Manufactured in the USA with
domestic and imported ingredients

Lot No:
Exp. Date

SPL UNCLASSIFIED SECTION

Learn more about the
story of Tom & Lyn at:
www.tomlyn.com

Promote healing and deter chewing of
wounds with Hot Spot Spray for dogs.
- Tom & Lyn

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

since 1976
tomlyn®
VETERINARY SCIENCE

NDC: 47171-010-04

HOT SPOT SPRAY
WITH BITTRAN II™ FOR DOGS

ALLERCAINE™

ANTISEPTIC ANTI-ITCH

• Soothes 'hot spots' & insect bites
• Helps control scratching & spot
  chewing
• Lidocaine reduces pain & itching
• Benzalkonium chloride helps
  prevent infection

ALL
DOGS

Veterinarian formulated.
Trusted since 1976.

NET CONTENTS:
4 fl oz (118 mL)

INGREDIENTS AND APPEARANCE

ALLERCAINE WITH BITTRAN II 
lidocaine hydrochloride and benzalkonium chloride spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 47171-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)	Lidocaine Hydrochloride Anhydrous	24 mg  in 1 mL
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
PEG-75 Lanolin (UNII: 09179OX7TB)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Hydroxymethyl Cellulose (UNII: 273FM27VK1)
Cetrimonium Bromide (UNII: L64N7M9BWR)
Allantoin (UNII: 344S277G0Z)
Denatonium Benzoate (UNII: 4YK5Z54AT2)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47171-010-12	355 mL in 1 BOTTLE, PLASTIC
2	NDC: 47171-010-04	118 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/29/1999

Labeler - Tomlyn Products, a Division of Vetoquinol USA, Inc. (037730194)

Registrant - Vetoquinol USA, Inc. (106824209)

Establishment
Name	Address	ID/FEI	Business Operations
American Pharmaceuticals and Cosmetics, Inc.		038023805	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
R. Mason (Chemicals) Ltd.		213246044	API MANUFACTURE