Label: OATMEAL DAILY MOISTURIZING 8OZ.- dimethicone 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 September 8, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Dimethicone 1.3% ......... Skin Protectant

  • PURPOSE

    Skin protectant

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Uses

    • Temporarily protects chafed, chapped or cracked skin

  • WARNINGS

    Warnings For external use only.

    When using this product avoid contact with eyes. In case of eye contact, flush with water.

    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.

    Do not use on

    • Deep or puncture wounds
    • Animal bites
    • Serious burns
  • DOSAGE & ADMINISTRATION

    Directions apply liberally as often as needed.

  • OTHER SAFETY INFORMATION

    Other Information store at room temperature.

    DISTRIBUTED BY

    GREENBRIER INTERNATIONAL, INC.

    500 VOLVO PARKWAY, CHESAPEAKE,VA 23320

    MADE IN CHINA

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Petrolatum, Isopropyl Myristate, Glycerin, Glyceryl Stearate, Propylene Glycol, PEG-100 Stearate, Polyacrylamide, Cetyl Alcohol, Avena Sativa (Oat) Kernel Extract, Fragrance, DMDM Hydantoin, Stearyl Alcohol, C13-14 Isoparaffin, Laureth-7, Disodium EDTA, Methylparaben, Propylparaben.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    OATMEAL DAILY MOISTURIZING 8OZ. 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-514
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE3 g  in 227 g
    Inactive Ingredients
    Ingredient NameStrength
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-514-01227 g in 1 BOTTLE; Type 0: Not a Combination Product10/10/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/10/2018
    Labeler - Family Dollar Services, Inc. (024472631)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(55319-514)
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