MEDICATED ANTI-ITCH- pramoxine and lidocaine spray

Medicated Anti-Itch by

Drug Labeling and Warnings

Medicated Anti-Itch by is a Animal medication manufactured, distributed, or labeled by Nootie, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:                             Purpose
Pramoxine HCL (1% w/w)            External analgesic
Lidocaine HCL (1% w/w)             External analgesic

INDICATIONS & USAGE

Uses: An anti-itch spray that calms, soothes and temporarily relieves pain and itching caused by insect bites and other minor allergic problems in dogs.

Directions: Spray daily on affected local areas or as directed by your veterinarian.

GENERAL PRECAUTIONS

Warnings:

• For animal use only
• For topical use on dogs
• Avoid contact with eyes or mucous membranes
• If eye contact occurs, rinse thoroughly with water. If irritation continues, consult your veterinarian
• Wash hands after using
• Keep out of reach of children
• If using other medications, consult your veterinarian prior to use

STORAGE AND HANDLING

Storage: Store at room temperature (59°F-86°)

SPL UNCLASSIFIED SECTION

Who said a medicated spray couldn’t smell amazing? Nootie’s gentle soap-free formula combined with our active medicated ingredients will help relieve your dog’s skin from itching and scratching.

MADE IN USA

Nootie

Manufactured and distributed by

Nootie LLC, 1 SE 4th Ave, Delray Beach, FL 33483

1-800-478-7713 Nootie.com

Product # DSAI08

811048021328

PRINCIPAL DISPLAY PANEL

Nootie

DERMATOLOGY

SOLUTIONS

Medicated

ANTI-ITCH SPRAY

RELIEVES ITCHING AND SCRATCHING

MAXIMUM STRENGTH

FOR DOGS

1% Pramoxine HCL, USP, 1% Lidocaine HCL, USP

with Colloidal Oatmeal

8 fl oz (237 ml)

INGREDIENTS AND APPEARANCE

MEDICATED ANTI-ITCH 
pramoxine and lidocaine spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 51437-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	1 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51437-202-08	237 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/2016

Labeler - Nootie, LLC (008995795)