Ceraven: Product Information

CERAVEN- 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.

Ceraven

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

Ceraven

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
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 16 OUNCE (473 mL) Bottle

Inspired by veterinarians

Ceraven

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
(click image for full-size original)
CERAVEN
pramoxine hydrochloride shampoo
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-6984
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM C14-16 OLEFIN SULFONATE
PEG-7 GLYCERYL COCOATE
SODIUM CHLORIDE
DISODIUM COCOAMPHODIACETATE
COCAMIDOPROPYL BETAINE
GLYCERIN
SODIUM LACTATE
AVENANTHRAMIDES
CERAMIDE 1
CERAMIDE EOS
CERAMIDE NP
SAFFLOWER OIL
PEG-8 LAURATE
LAURETH-4
CITRIC ACID MONOHYDRATE
POTASSIUM SORBATE
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11695-6984-1 237 mL in 1 BOTTLE, PLASTIC None
2 NDC:11695-6984-2 473 mL in 1 BOTTLE, PLASTIC None
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)

Revised: 04/2021 BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA

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