CERASOOTHE- pramoxine hydrochloride shampoo 
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 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: 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.

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 CONDITIONS: Store at room temperature. Do not freeze.

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)

8 ounce bottle label

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)

16 ounce bottle label

CERASOOTHE 
pramoxine hydrochloride shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-6984
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11695-6984-1237 mL in 1 BOTTLE, PLASTIC
2NDC:11695-6984-2473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/02/2021
Labeler - BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA (603750329)
Registrant - Ceva Sante Animale (261126049)

Revised: 5/2022
Document Id: b495175e-d903-44d1-93ea-085eedf41493
Set id: c063a87b-244f-44d9-9fd3-77f2c166bc4a
Version: 2
Effective Time: 20220524
 
BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA