Label: RE/COVER KIT- colloidal oatmeal kit

  • Category: HUMAN OTC 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 August 22, 2023

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  • Drug Facts

  • Active ingredient

    Colloidal oatmeal 1%

  • Purpose

    Skin protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritation and itching due to eczema

  • Warnings

    For external use only.

    When using this product, do not get into eyes.

    Stop use and ask a doctor if,

    • Condition worsens
    • Symptoms last more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children. If swallowed, get medical help of contact a Poison Control Center right away.

  • Directions

    Apply to affected areas of skin as illustrated in the USAGE INSTRUCTIONS.

  • Other information

    store at room temperature

  • Inactive ingredients

    water, glycerin, cetearyl alcohol, petrolatum, stearic acid, C12-15 alkyl benzoate, dimethicone, aesculus hippocastanum (horse chestnut) seed extract, laureth-3, hydroxyacetophenone, ceteareth-20, allantoin, arginine, sodium hydroxide, carbomer, panthenol, tetrasodium glutamate diacetate, phenoxyethanol

  • Questions or comments?

    1-800-309-1638

  • Moisture Patch Instructions

    instructions

  • MOISTURE PATCH INGREDIENTS

    Polyvinyl butyral, PEG-60 hydrogenated castor oil, butylene glycol

  • PRINCIPAL DISPLAY PANEL

    re/cover™

    ECZEMA RELIEF SYSTEM

    Fast-acting system quickly relieves the disruption and discomfort of eczema with a soothing serum and invisible protective moisture patch to help recover healthy-looking skin

    +CALMING ECZEMA SERUM

    COLLOIDAL OATMEAL SKIN PROTECTANT

    +MOISTURE PATCHES

    • Serum helps to shorten eczema flare ups and relieve the itch
    • Dermatologist Tested
    • Steroid Free

    7 DAY SYSTEM

    14 MOISTURE PATCHES

    0.30 FL OZ (9 mL) CALMING ECZEMA SERUM

    For additional information:

    www.recoverskincare.com

    or 1-800-309-1638

    RE/COVER is a trademark of Kao Corp.

    Distributed by Kao USA Inc.

    Cincinnati, OH 45214

    ©2023

    Patch: Made in Japan.

    Serum: Made in USA of US & Imported Ingredients

    label

  • INGREDIENTS AND APPEARANCE
    RE/COVER KIT 
    colloidal oatmeal kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10596-901
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10596-901-031 in 1 KIT; Type 0: Not a Combination Product08/21/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 BOTTLE, WITH APPLICATOR 1 mL
    Part 1 of 1
    RE/COVER SERUM 
    colloidal oatmeal emulsion
    Product Information
    Item Code (Source)NDC:10596-902
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    ARGININE (UNII: 94ZLA3W45F)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LAURETH-3 (UNII: F32E4CB0UJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    19 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01608/21/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/21/2023
    Labeler - KAO USA (004251617)
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