Label: CERASOOTHE- pramoxine hydrochloride shampoo
- NDC Code(s): 11695-6984-1, 11695-6984-2
- Packager: BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated May 24, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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.
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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
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle
- PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle
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INGREDIENTS AND APPEARANCE
CERASOOTHE
pramoxine hydrochloride shampooProduct 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)
