Label: ALLERCAINE WITH BITTRAN II- lidocaine hydrochloride and benzalkonium chloride spray
- NDC Code(s): 47171-010-04, 47171-010-12
- Packager: Tomlyn Products, a Division of Vetoquinol USA, Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated October 5, 2018
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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.
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:
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
HOT SPOT SPRAY
WITH BITTRAN II™ FOR DOGS
ANTISEPTIC • ANTI-ITCH
- Soothes 'hot spots' & insect bites
- Helps control scratching & spot
- Lidocaine reduces pain & itching
- Benzalkonium chloride helps
Trusted since 1976.
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