Label: CERASOOTHE P ANTI-ITCH MOUSSE- pramoxine hydrochloride liquid
- NDC Code(s): 11695-6985-1
- 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 26, 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 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.
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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: 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
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 6.8 OUNCE (200 mL) Bottle
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INGREDIENTS AND APPEARANCE
CERASOOTHE P ANTI-ITCH MOUSSE
pramoxine hydrochloride liquidProduct 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)
