CERASOOTHE- pramoxine hydrochloride shampoo

CeraSoothe by

Drug Labeling and Warnings

CeraSoothe by is a Animal medication manufactured, distributed, or labeled by BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA, Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

CeraSoothe

PRAMOXINE

Anti-Itch Shampoo

Fragrance: Cucumber melon

Pramoxine HCl 1%

Formulated for cats, dogs and horses

A conditioning shampoo with pramoxine to help relieve itching and skin irritations. Ceramides and avenanthramides are skin nourishing nutrients that moisturize and calm the skin. They also support the skin's natural immune system and provide building blocks for renewed skin barrier integrity.

Active ingredient: Pramoxine HCI 1%.

Inactive ingredients: Water, sodium C14-16 olefin sulfonate, PEG-7 glyceryl cocoate, sodium chloride, disodium cocoamphodiacetate, cocamidopropyl betaine, glycerin, sodium lactate, avena sativa (oat) kernal extract, ceramide EOP, ceramide EOS, ceramide NP, carthamus tinctorius (safflower) seed oil, PEG-8, laurate, laureth-4, fragrance, citric acid, potassium sorbate, methylchloroisothiazolinone, methylisothiazolinone.

INDICATIONS & USAGE

Indications: For use on cats, dogs and horses for the temporary relief of itching and skin irritations.

Directions for use:  Bathe 2-3 times per week until symptoms subside or as directed by your veterinarian. Wet the animal with cool water from the neck down and apply shampoo first on the skin abnormalities. Starting with a quarter-size amount of product, massage into the fur to reach the skin. Repeat until the entire body is lightly coated with shampoo. Leave shampoo on for 10 minutes before rinsing with cool water. Wash hands after use. For a rinse-free solution between baths, use Ceraven Pramoxine anti-itch mousse.

WARNINGS AND PRECAUTIONS

Cautions: For external use on cats, dogs and horses only. Avoid contact with eyes. In case of contact with eyes, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian.

STORAGE AND HANDLING

STORAGE CONDITIONS: Store at room temperature. Do not freeze.

SPL UNCLASSIFIED SECTION

Distributed by:

Covetrus North America

400 Metro Place North

Dublin, OH 43017

covetrus.com

QUESTIONS?

(855) 724-3461

PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

Inspired by veterinarians

CeraSoothe

PRAMOXINE

Anti-itch Shampoo

Fragrance: Cucumber melon

Pramoxine HCl 1%

Formulated for cats, dogs and horses

Keep out of reach of children

For animal use only

NDC: 11695-6984-1

Net contents: 8 fl oz (237 mL)

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

Inspired by veterinarians

CeraSoothe

PRAMOXINE

Anti-itch Shampoo

Fragrance: Cucumber melon

Pramoxine HCl 1%

Formulated for cats, dogs and horses

Keep out of reach of children

For animal use only

NDC: 11695-6984-2

Net contents: 16 fl oz (473 mL)

INGREDIENTS AND APPEARANCE

CERASOOTHE 
pramoxine hydrochloride shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-6984
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LACTATE (UNII: TU7HW0W0QT)
AVENANTHRAMIDES (UNII: 5PA41O4AIT)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE EOS (UNII: CR0J8RN66K)
CERAMIDE NP (UNII: 4370DF050B)
SAFFLOWER OIL (UNII: 65UEH262IS)
PEG-8 LAURATE (UNII: 762O8IWA10)
LAURETH-4 (UNII: 6HQ855798J)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-6984-1	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 11695-6984-2	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/02/2021

Labeler - BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA (603750329)

Registrant - Ceva Sante Animale (261126049)