Label: CHEW PLUS HEAL HYDROCORTISONE- hydrocortisone acetate lotion

  • NDC Code(s): 86173-812-04, 86173-812-08
  • Packager: Click Industries LLC
  • 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 March 5, 2024

If you are a consumer or patient please visit this version.

  • DRUG FACTS

    Active Ingredients 

    Hydrocortisone acetate

    (Equivalent to Hydrocortisone 0.5%)

  • PURPOSE

    Purpose

    Antipruritic (Anti-Itch)

    Anti-Inflammatory

  • Uses

    Helps soothes: • Flea bites • Dermatitis • Skin irritations • Moist eczema • Inflammations • Itching

  • WARNINGS:

    For external use on dogs only.
    Keep out of the reach of children and animals.
    Avoid contact with eyes (dogs or people)

  • DIRECTIONS FOR USE​

    Pre-bathe the animal with a mild shampoo and dry thoroughly. If necessary, spread coat apart with fingers to expose irritated area. Massage lotion directly on the affected area. Only a thin coat is necessary. Small applications at frequent intervals gives the best results. For long-haired breeds, it may be necessary to clip hair from the irritated area to expose skin. Use an Elizabethan Collar (E-Collar), if necessary, to keep pet from licking the medicine while being treated.

  • Storage:

    Store at temperature between 66-77°F.

  • Do not use:

    • When redness, irritation, or swelling persists or increases • When product seal is broken

  • Inactive Ingredients:

    Aloe Barbadensis Leaf juice, Carbomer, Cetyl Alcohol, Ethylhexylglycerin, Fragrance/Parfum, Isopropyl Myristate, Mineral Oil, Phenoxyethanol, Propanediol, Sodium Borate, Stearic acid, Synthetic Beeswax, Water (Aqua)

  • SPL UNCLASSIFIED SECTION

    REDUCES SWELLING & ITCHING

    FOR DOGS

    Manufactured For: Chew + Heal
    Surfside, FL
    www.chewandheal.com
    MADE IN U.S.A
    with globally sourced ingredients

  • Packaging

    chewheal

  • INGREDIENTS AND APPEARANCE
    CHEW PLUS HEAL HYDROCORTISONE 
    hydrocortisone acetate lotion
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86173-812
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86173-812-04118 mL in 1 BOTTLE
    2NDC:86173-812-08237 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/17/2023
    Labeler - Click Industries LLC (117033580)