CERASOOTHE P ANTI-ITCH MOUSSE- pramoxine hydrochloride liquid

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 Mousse

Fragrance: Cucumber melon

Formulated for cats, dogs, and horses

A leave-on mousse with pramoxine to help relieve itching and skin irritations. Ceramides and avenanthramides are skin nourishing nutriients that moisturize and calm the skin. The also support the skin's natural immune system and provide building blocks for renewed skin barrier integrity.

Active ingredients: Pramoxine HCl 1%.

Inactive ingredients: Water, glycerin, PEG-8 dimethicone, polysorbate 80, poloxamer 184, sodium lactate, aloe barbadensis (aloe) leaf juice, avena sativa (oat) kernel extract, ceramide EOP, ceramide EOS, ceramide NP, fragrance, potassium sorbate, methylisothiazolinone.

INDICATIONS & USAGE

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

Directions for use: Brush the fur then apply product on dry hair. Apply every 3 days for 2-3 weeks or as directed by your veterinarian. Wash hands after use.

For localized application:​ Dispense 1 - 2 pumps onto your palm, then apply on the targeted area(s). Massage into the skin until fully penetrated. Do not rinse, let air dry. Once dry, brush the fur again.

For whole body application:  Dispense 1 or 2 pumps onto your palm, then apply on the skin and hair. Massage into the skin until fully penetrated. Repeat as necessary to cover the whole body, avoiding the eyes and mouth. Do not rinse, let air dry. Once dry, brush the fur again.

Dosage:

Under 11 lbs: 1 pump per 2 lbs

11-88 lbs: 1 pump per 4 lbs

Over 88 lbs: 1 pump per 6 lbs

Dosage may be doubled for long-haired dogs.

For deeper cleansing, use Ceraven Pramoxine anti-itch shampoo.

WARNINGS AND PRECAUTIONS

Cautions: For external use on cats, dogs or 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: Store at room temperature. Do not freeze.

SPL UNCLASSIFIED SECTION

QUESTIONS?

(855) 724-3461

Distributed by:

Covetrus North America

400 Metro Place North

Dublin, OH 43017

covetrus.com

PRINCIPAL DISPLAY PANEL - 6.8 OUNCE (200 mL) Bottle

Inspired by veteriarians

CeraSoothe PRAMOXINE

Anti-itch Mousse

Fragrance: Cucumber melon

Pramoxine HCl 1%

Formulated for cats, dogs, and horses

Keep out of reach of children

For animal use only

NDC: 11695-6985-1

Net Contents: 6.8 fl oz (200 mL)

covetrus

INGREDIENTS AND APPEARANCE

CERASOOTHE  P ANTI-ITCH MOUSSE
pramoxine hydrochloride liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-6985
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)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLOXAMER 184 (UNII: BIS92ZSF57)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AVENANTHRAMIDES (UNII: 5PA41O4AIT)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE EOS (UNII: CR0J8RN66K)
CERAMIDE NP (UNII: 4370DF050B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-6985-1	200 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/22/2021

Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)

Registrant - Ceva Sante Animale (261126049)