Label: SKIN RELIEF OATMEAL DAILY MOISTURIZING- 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 December 16, 2018

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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

    Use help prevent and temporarily protets 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.

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    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.

  • 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
    SKIN RELIEF OATMEAL DAILY MOISTURIZING 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OAT (UNII: Z6J799EAJK)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-114-01227 g in 1 TUBE; Type 0: Not a Combination Product12/16/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/16/2018
    Labeler - China Ningbo Shangge Cosmetic Technology Corp (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp529287434manufacture(58503-114)
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