CERASOOTHE P ANTI-ITCH MOUSSE- pramoxine hydrochloride liquid 
Butler Animal Health Supply, LLC dba Covetrus North America

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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: 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.

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: Store at room temperature. Do not freeze.

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

200 mL bottle label

CERASOOTHE  P ANTI-ITCH MOUSSE
pramoxine hydrochloride liquid
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-6985
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11695-6985-1200 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/22/2021
Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)
Registrant - Ceva Sante Animale (261126049)

Revised: 5/2022
Document Id: b96b867f-a787-4a47-a3e9-f55e285697ed
Set id: 7cdde388-b7de-4ad7-8c37-2b6adc0de4d5
Version: 2
Effective Time: 20220526
 
Butler Animal Health Supply, LLC dba Covetrus North America