MEDICATED ANTI-ITCH- pramoxine and lidocaine shampoo

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 shampoo that calms, soothes and temporarily relieves pain and itching caused by insect bites and other minor allergic problems in dogs.

Directions: Thoroughly wet animal's coat. Apply sufficient amounts of shampoo to work into a rich lather. Allow lather to stay on animal for 5 to 8 minutes, then rinse completely. Repeat if necessary 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 medicated shampoo couldn’t smell amazing? Nootie’s gentle soap-free formula combined with our active medicated ingredients will help restore and relieve your dog’s skin from itching and scratching leaving your dog's coat shiny, soft and smelling amazing.

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 # SAI16

811048021304

PRINCIPAL DISPLAY PANEL

Nootie

DERMATOLOGY

SOLUTIONS

Medicated

ANTI-ITCH SHAMPOO

RELIEVES ITCHING AND SCRATCHING

MAXIMUM STRENGTH

FOR DOGS

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

with Colloidal Oatmeal

16 fl oz (474 ml)

INGREDIENTS AND APPEARANCE

MEDICATED ANTI-ITCH 
pramoxine and lidocaine shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 51437-201
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: 51437-201-04	118 mL in 1 BOTTLE, PLASTIC
2	NDC: 51437-201-08	237 mL in 1 BOTTLE, PLASTIC
3	NDC: 51437-201-16	474 mL in 1 BOTTLE, PLASTIC
4	NDC: 51437-201-28	3785 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)