Label: RITE-AID ECZEMA RELIEF- colloidal oatmeal cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 3, 2021

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  • ACTIVE INGREDIENT

    Active ingredient

    Colloidal oatmeak 2%

  • PURPOSE

    Purpose

    Skin protectant

  • INDICATIONS & USAGE

    Uses temporarily protects and helps relieve minor skin

    irritation and itching due to •eczema  •rashes

  • WARNINGS

    Warnings

    For external use only.

    When using this product  •avoid contact with eyes

    Stop use and ask a doctor if condition worsens

    •symptoms persist for more than 7 days or clear up and

    occur again within a few days.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical

    help or contact a Poison Contorl Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    apply to affected areas of skin as needed

  • INACTIVE INGREDIENT

    Inactive ingredients water, glycerin, propanediol,

    dimethicone, petrolatum, glyceryl stearate, cetyl alcohol,

    aloe barbadensis leaf juice, jojoba etsers, polyacrylate-13,

    polyisobutene, polysorbate 20, butyrosperum parkii

    (shea) butter extract, avena sativa (0at) kernel extract,

    bisabolol, zingiber officinale (ginger) root extract, C10-30

    cholseterol.lanosterol esters, ceramide NG, hydrolyzed

    jojoba esters, tocopheryl acetate, magnesium ascorbyl

    phosphate, panthenol, ethylhexylglycerin, C12-15 alkyl

    benzoate, tribehenin, lactic acid, disodium EDTA,

    phenoxyethanol, hippophae rhamnoides oil, PEG-10

    phylosterol, palmitoyl hexapeptide-12.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    RITE-AID  ECZEMA RELIEF
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-5332
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL4.52 g  in 226 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    AMMONIUM ACRYLOYL DIMETHYLTAURATE/METHACRYLATE, DIMETHYLACRYLAMIDE AND METHACRYLIC ACID COPOLYMER, PPG-3 GLYCERYL TRIACRYLATE CROSSLINKED (100000 MW) (UNII: WR7H9IW2XX)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    OAT (UNII: Z6J799EAJK)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    GINGER (UNII: C5529G5JPQ)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    LANOSTEROL (UNII: 1J05Z83K3M)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)  
    PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-5332-1226 g in 1 TUBE; Type 0: Not a Combination Product04/10/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/10/2018
    Labeler - Rite Aid Corporation (014578892)
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