Label: DR FROG WATER FULL CHARGE- dimethicone 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 April 13, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients: Dimethicone 1.5%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    WATER,ANGELICA ARCHANGELICA ROOT WATER,ONSEN-SUI,ROSA DAMASCENA FLOWER WATER,GLYCERIN,HYDROGENATED POLYDECENE,DIPROPYLENE GLYCOL,CETEARETH-6 OLIVATE,LIMNANTHES ALBA (MEADOWFOAM) SEED OIL,1,2-HEXANEDIOL,CAPRYLIC/CAPRIC TRIGLYCERIDE,PEG/PPG-17/6 COPOLYMER,DIISOSTEARYL MALATE,CETEARYL ALCOHOL,DIETHYLHEXYL CARBONATE,OLEA EUROPAEA (OLIVE) FRUIT OIL,STEARIC ACID,BUTYLENE GLYCOL,GLYCERYL CAPRYLATE,GLYCOSYL TREHALOSE,CETYL PALMITATE,SORBITAN OLIVATE,SORBITAN PALMITATE,AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER,HYDROLYZED JOJOBA ESTERS,HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER,ANGELICA ARCHANGELICA EXTRACT,HYACINTHUS ORIENTALIS (HYACINTH) EXTRACT,HYDROGENATED STARCH HYDROLYSATE,SQUALANE,TOCOPHERYL ACETATE,ALLANTOIN,XANTHAN GUM,ALOE BARBADENSIS LEAF JUICE, ULMUS DAVIDIANA ROOT EXTRACT,SACCHAROMYCES/RUBUS COREANUS FRUIT FERMENT FILTRATE,POLYSORBATE 60,DIOSPYROS KAKI LEAF EXTRACT,GLYCERYL ACRYLATE/ACRYLIC ACID COPOLYMER,CAPRYLYL GLYCOL,DISODIUM EDTA,SORBITAN ISOSTEARATE,ETHYLHEXYLGLYCERIN,SODIUM HYALURONATE,BACILLUS/SOYBEAN FERMENT EXTRACT,ASCORBYL TOCOPHERYL ACETATE,HYDROGENATED LECITHIN,SUCROSE PALMITATE,ALCOHOL,CRINUM ASIATICUM EXTRACT,CERAMIDE NP,C8-12 ACID TRIGLYCERIDE,CHOLESTEROL,POLYSORBATE 80,PHYTOSPHINGOSINE,LACTIC ACID,OLEIC ACID,WINE EXTRACT,FRAGRANCE

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings:

    1) Please stop using the product if the following symptoms occur or appear when the skin is exposed to direct sunlight: red blotches, swelling, itchiness or other irritations while using product. Then, consult a dermatologist or a specialist.

    2) Please do not apply the product on wound or any of skin irritation, such as eczema or dermatitis.

    3) Precaution during storage/handling. a) Keep the product closed after using b) Keep out of reach of children c) Avoid storing in high and low temperature and areas exposed to direct sunlight

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses:

    Moisture cream that penetrates all over the skin and relieves chronic dryness with full moisture.

    1. Relieves skin drought Sudden absorption with mineral water basis, enables relieving skin drought

    2. Forms shield for the moisture layer Forms a long-term shield for the moisture layer, in order to prevent loss of effective moisture particles. 3. Dual care effect Elasticity care, along with balanced formula keeps your skin elastic and tight, all the time.

  • Directions

    Directions:

    Apply an appropriate amount and spread all over the face, accordingly following the skin texture softly in the morning∙evening cream steps.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DR FROG WATER FULL CHARGE 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22201-1010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.75 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22201-1010-21 in 1 CARTON03/01/2018
    1NDC:22201-1010-150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2018
    Labeler - Charmzone Co Ltd (689049765)
    Registrant - Charmzone Co Ltd (689049765)
    Establishment
    NameAddressID/FEIBusiness Operations
    Charmzone Co., Ltd._Wonju Factory688238394manufacture(22201-1010)