Label: DOUBLE S ESSENCE CLEAN- glycerin gel

  • 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 May 10, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Glycerin 25.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Aqua, Butylene Glycol, Sodium Hyaluronate, Sodium Polyacrylate, Triethanolamine, Carbomer, Silica, Zinc, Silver, Citric Acid

  • PURPOSE

    Purpose: Skin protectant

  • WARNINGS

    Warnings: Avoid a high and low temperature and keep this out of direct sunlight. Just stop using when more than skin redness you use it. DOUBLE.S is not for birth control. It is impossible to protect 100% from venereal diseases or infection.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Indications & usage: Penis or intimate area, apply it enough.

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Apply following amount 2~3g over the area

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DOUBLE S ESSENCE CLEAN 
    glycerin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70654-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin3.75 g  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70654-010-021 in 1 CARTON04/01/2016
    1NDC:70654-010-0115 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/01/2016
    Labeler - EINS CORPORATION (689605622)
    Registrant - EINS CORPORATION (689605622)
    Establishment
    NameAddressID/FEIBusiness Operations
    EINS CORPORATION689605622manufacture(70654-010)
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