TOUGH SEAL HOT SPOT PLUS PAIN RELIEF- lidocaine spray

Tough Seal Hot Spot plus Pain Relief by

Drug Labeling and Warnings

Tough Seal Hot Spot plus Pain Relief by is a Animal medication manufactured, distributed, or labeled by Kericure Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients:

Lidocaine 1%

Purpose:

Topical anasthetic

INDICATIONS & USAGE

Uses: For the temporary relief of pain and itch in minor cuts, burns, scrapes, skin irritations, insect bites and sunburn

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Do not ingest. For use on dogs, cats, horses and other small animals.

Keep away from children 2 years of age and younger.

DOSAGE & ADMINISTRATION

Directions: Shake well then apply firm spray.

DO NOT RUB IN. Allow a thin, clear film to set. Barrier is invisible once dry and safe if licked. Apply up to 3x a day for 7 days. Consult a veterinarian if condition worsens.

INACTIVE INGREDIENT

Inactive Ingredients: Purified water, ethanol, polyacrylate polymer, cellulose

SPL UNCLASSIFIED SECTION

HOT SPOT PAIN RELIEF HYDROGEL

Relieve & protect hot spots, rashes, skin irritations & more!

340 SPRAYS

Made in the USA

TOUGH SEAL®

Soothe, Seal & Protect®

Questions? info@Kericure.com

Kericure Inc. Baltimore, MD 21229

KeriCure®.com

Packaging

INGREDIENTS AND APPEARANCE

TOUGH SEAL HOT SPOT PLUS PAIN RELIEF 
lidocaine spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 78280-702
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78280-702-20	55 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/22/2020

Labeler - Kericure Inc. (966638681)