Label: BATHSCRIPTIONS 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 October 12, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient:

    Dimethicone 2.0%

  • PURPOSE

    Purpose:

    Skin Protectant

  • INDICATIONS & USAGE

    Uses:

    Helps prevent and temporarily protects chafted, chapped or cracked skin. Helps prevent and protect from the drying effect of wind and cold weather

  • WARNINGS

    Warnings:

    For external use only

    When using this product, do not get into eyes

  • STOP USE

    Stop use and ask a doctor if condition worsens or if symptoms last 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 Control Center immediately

  • DOSAGE & ADMINISTRATION

    Direction:

    Apply as needed

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water, Isopropyl Palmitate, Avena sativa (Oat) Flour, Cetyl Alcohol, Glycerin, Distearyldimonium Chloride, Benzyl Alcohol, Sodium Chloride

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BATHSCRIPTIONS DAILY MOISTURIZING 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70990-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70990-001-01200 mL in 1 TUBE; Type 0: Not a Combination Product10/12/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/12/2016
    Labeler - Donegal Bay Ltd (068443618)
    Registrant - Donegal Bay Ltd (068443618)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANGZHOU KARIC COMMODITIES CO., LTD526884335manufacture(70990-001)
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