Label: PRAMOX CREME RINSE- pramoxine hydrochloride rinse

  • NDC Code(s): 68898-122-16
  • Packager: Animal Pharmaceuticals
  • 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 October 19, 2021

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  • Drug Facts

  • Active Ingredients

    Pramoxine HCl, USP 1%

  • Purpose

    Topical Anesthetic

  • Inactive Ingredients

    Water, Cetearyl Alcohol, PEG-40 Hydrogenated Castor Oil, Stearalkonium Chloride, Hydrolyzed Oats, Hydrolyzed Wheat Protein, Polysorbate-60, Glycerin, Dimethicone, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Hydroxide.

  • Uses:

    a medicated creme rinse for the temporary relief of itching and scratching on dogs, cats and horses with dermatological conditions responsive to pramoxine.

  • Directions for Use:

    Shake well before using. Apply Creme Rinse evenly over and into the hair coat and rub in well. Rinse well and repeat the procedure if desired. May be used as often as necessary.

  • Precautions

    For topical use on animals only. If redness or irritation persists or increases, discontinue use and consult a veterinarian. Avoid contact with the eyes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of contact with eyes or mucous membranes, flush with copious amounts of water for 5-10 minutes. If irritation persists seek medical attention immediately.

  • SPL UNCLASSIFIED SECTION

    Anti-itch Creme Rinse

    For Temporary Relief Of Dermatological Conditions Responsive To Pramoxine.

    Tropical Guava

    Formulated for Dogs, Cats & Horses

    At Animal Pharmaceuticals we strive to provide the best nutritional and topical treatments for your pet by going above and beyond...and we don't stop there. We know that caring for your pet is just as important as caring for your own health, so we've developed and implemented systems that make things easier on you and convenient for your veterinarian.

    OUR ASSURANCE
    Animal Pharmaceuticals products are designed with our proprietary technology that helps retrieve and sustain the nutrients and healthful ingredients. Our proprietary formulation enhances the effects of functional ingredients and penetrates the skin and the effective areas to exert the corrective results.

    Additionally, and as always, you'll find that all our bottles and containers are made of recyclable plastic. Please help us protect the environment by recycling.

    ALL PRODUCTS ARE MADE IN THE U.S.A. 

    To learn more about our products, visit:

    www.anmpharm.com

    SOLD EXCLUSIVELY THROUGH LICENSED VETERINARIANS

    MANUFACTURED FOR
    Animal Pharmaceuticals

    MADE IN THE USA

  • Packaging

    anmpharm-122

  • INGREDIENTS AND APPEARANCE
    PRAMOX CREME RINSE 
    pramoxine hydrochloride rinse
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:68898-122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)  
    OAT (UNII: Z6J799EAJK)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68898-122-16474 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/15/2021
    Labeler - Animal Pharmaceuticals (166472444)
    Registrant - Stratford Care Usa, Inc. (036650469)
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Safety

Report Adverse Events (Animal Drug), FDA Safety Recalls (Animal Drug)

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Clinical Trials, PubMed, Biochemical Data Summary

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