Label: CVS HEALTH ECZEMA SKIN RELIEF SKIN PROTECTANT- oatmeal lotion

  • 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 January 29, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Colloidal oatmeal 2.0%

  • Purpose

    Skin protectant

  • Uses

    temporarily protects and helps relieve minor skin irritation and itching due to

    ⬥
    eczema
    ⬥
    rashes
  • Warnings

    For external use only

    When using this product avoid contact with 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 or contact a Poison Control Center right away.

  • Directions

    apply as needed or as directed by a doctor

  • Other information

    store at room temperature

  • Inactive ingredients

    water, glycerin, glyceryl stearate, cetearyl alcohol, ceteareth-20, propanediol, dimethicone, cetyl alcohol, hydrolyzed jojoba esters, petrolatum, tetrasodiun EDTA, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 60, aloe barbadensis leaf juice, avena sativa (oat) kernel extract, butyrospermum parkii (shea) butter extract, zingiber officinale (ginger) root extract, C12-15 alkyl benzoate, panthenol, ceramide NP, tocopheryl acetate, magnesium ascorbyl phosphate, bisabolol, citric acid, benzyl alcohol, ethylhexylglycerin.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    CVS Pharmacy, Inc.
    One CVS Drive
    Woonsocket, RI 02895

  • PRINCIPAL DISPLAY PANEL - 396 g Bottle Label

    CVS
    Health™

    Compare to
    Gold Bond®
    Ultimate Eczema
    Relief Lotion*

    Eczema
    Skin Relief
    Lotion

    2% COLLOIDAL OATMEAL
    SKIN PROTECTANT LOTION

    • Helps relieve symptoms of eczema
    • Helps to relieve itching, dryness
      & irritation due to eczema
    • Steroid & fragrance free
    • Dermatologist tested
    • Paraben & phthalate free

    with Natural
    Colloidal Oatmeal

    NET WT 14 OZ (396 g)

    05-3627

    PRINCIPAL DISPLAY PANEL - 396 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH ECZEMA SKIN RELIEF   SKIN PROTECTANT
    oatmeal lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-962
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y) Oatmeal20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Propanediol (UNII: 5965N8W85T)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Hydrolyzed Jojoba Esters (Acid Form) (UNII: UDR641JW8W)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Edetate Sodium (UNII: MP1J8420LU)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    Isohexadecane (UNII: 918X1OUF1E)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Oat (UNII: Z6J799EAJK)  
    Shea Butter (UNII: K49155WL9Y)  
    Ginger (UNII: C5529G5JPQ)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Panthenol (UNII: WV9CM0O67Z)  
    Ceramide NP (UNII: 4370DF050B)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Magnesium Ascorbyl Phosphate (UNII: 0R822556M5)  
    Levomenol (UNII: 24WE03BX2T)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-962-01396 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/03/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34712/03/2018
    Labeler - CVS Health (062312574)
    Registrant - Garcoa Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries Inc.255106239MANUFACTURE(69842-962)
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