Label: CYBERCY MAYER /KANG DU QING- poloxamer 188 gel

  • NDC Code(s): 68991-003-10
  • Packager: Shenzhen Senton Science & Technology Co. Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 13, 2022

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  • ACTIVE INGREDIENTS

    POLOXAMER 188   2.7%

  • PURPOSES

    Antimicrobial

  • USES

    For Vaginal Cleansing. Kills Germs.

  • WARNINGS:

    Keep out of reach of children.

  • WARNINGS:

    Discontinue use if any burning, itching, or irritation of the vagina occurs during use.

    Wash and douche with water. 


    Do not douche to prevent pregnancy.

    During pregnancy.

    Do not use during breast feeding.

    Do not use during period and 4 days after period ends.

    Children under 12 years of age do not use the product.

    If swallowed, get medical help or contact a poison control center right away.

    FOR EXTERNAL USE ONLY.

    Do not use in eyes.

  • DIRECTIONS:

    Insert the gel into the vagina when cleansing is desired, one tube each time before bed.

    Please read the following instructions carefully before use.

    1. Take off the package from bottom. Take out the applicator with caution and protect the small plastic tip from falling off the applicator.

    2. Remove the the front cap and treat it as holder of the applicator.

    3. Lie down and slowly insert the applicator into the vagina. When discomfort or resistance occurs, stops the applicator to prevent from injury. And gently release the gel for one time only.

    4. Remove the applicator slowly and keep lying down for 15 minutes.

    5. Discard it in a waste container.

    Do not use this product if the package seal is broken.

    CAUTION:

    Persons with skin allergy use with caution.

  • DOSAGE

    1 tube every day before bedtime

  • STORAGE

    Store in a cool and dry place away from direct sunlight at 20 - 25 degrees Centigrade or 68 - 77 degrees Fahrenheit.

  • INACTIVE INGREDIENTS

    COIX LACRYMA JOBI SEED, CURCUMA AMADA WHOLE, BITTER ALMOND, PEACH KERNEL OIL GLYCERETH-8 ESTERS, BORNEOL, ACACIA CATECHU BARK, BOSWELLIA SACRA WHOLE, COMMIPHORA MYRRHA WHOLE, DRAGON'S BLOOD, LACTARIUS INDIGO WHOLE,SULFUR, MENTHOL, PINELLIA TERNATA WHOLE, BRUCEA JAVANICA WHOLE, ARTEMISIA PRINCEPS LEAF OIL, POLYGALA TENUIFOLIA ROOT, ATRACTYLODES LANCEA ROOT, SALVIA MILTIORRHIZA ROOT, RUBIA CORDIFOLIA ROOT, OSTHOL, SPARGANIUM STOLONIFERUM WHOLE, GALLIC ACID MONOHYDRATE, PSEUDOLARIX AMABILIS BARK, SANGUISORBA OFFICINALIS ROOT, PERILLA FRUTESCENS LEAF, GENTIANA MANSHURICA WHOLE, EUPHORBIA AMYGDALOIDES, CHRYSANTHEMIN, SOPHORA FLAVESCENS ROOT, RHEUM OFFICINALE STEM, CORYDALIS BUNGEANA WHOLE, BLETILLA STRIATA WHOLE, CELOSIA CRISTATA FLOWER, COPTIS CHINENSIS ROOT, AGRIMONIA PILOSA WHOLE, PODOPHYLLUM RESIN, GELLAN GUM, LYSOZYME, CHICKEN EGG WHITE, LACTIC ACID, SODIUM DIACETATE, CITRIC ACID ACETATE, SODIUM POLYMETAPHOSPHATE, ROSE OIL, JASMINUM SAMBAC FLOWER

  • DRUG FACTS

    image description

  • INGREDIENTS AND APPEARANCE
    CYBERCY MAYER /KANG DU QING 
    poloxamer 188 gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68991-003
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLOXAMER 188 (UNII: LQA7B6G8JG) (POLOXAMER 188 - UNII:LQA7B6G8JG) POLOXAMER 1882.7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COIX LACRYMA-JOBI SEED (UNII: 4Q4V6NTZ1F)  
    CURCUMA AMADA WHOLE (UNII: 4F488G53MD)  
    BITTER ALMOND (UNII: O65SFW8R9A)  
    PEACH KERNEL OIL GLYCERETH-8 ESTERS (UNII: RY37QKW66H)  
    BORNEOL (UNII: M89NIB437X)  
    ACACIA CATECHU BARK (UNII: 996E9YN6SU)  
    BOSWELLIA SACRA WHOLE (UNII: 8O600AZL0W)  
    COMMIPHORA MYRRHA WHOLE (UNII: UU81N77RI7)  
    DRAGON'S BLOOD (UNII: M3YJ2C28IC)  
    LACTARIUS INDIGO WHOLE (UNII: 1VMC8612R2)  
    SULFUR (UNII: 70FD1KFU70)  
    MENTHOL (UNII: L7T10EIP3A)  
    PINELLIA TERNATA WHOLE (UNII: 71T2LKP8GL)  
    BRUCEA JAVANICA WHOLE (UNII: Z4CCI5NZ66)  
    ARTEMISIA PRINCEPS LEAF OIL (UNII: F9S1101A2V)  
    POLYGALA TENUIFOLIA ROOT (UNII: 5S7W573MTU)  
    ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O)  
    SALVIA MILTIORRHIZA ROOT (UNII: 1693AM5SBN)  
    RUBIA CORDIFOLIA ROOT (UNII: 4V873H15CG)  
    OSTHOL (UNII: XH1TI1759C)  
    SPARGANIUM STOLONIFERUM WHOLE (UNII: 873IV8AW3C)  
    GALLIC ACID MONOHYDRATE (UNII: 48339473OT)  
    PSEUDOLARIX AMABILIS BARK (UNII: 49G13A93VE)  
    SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    GENTIANA MANSHURICA WHOLE (UNII: EZ2YV7214M)  
    EUPHORBIA AMYGDALOIDES (UNII: I61HL17199)  
    CHRYSANTHEMIN (UNII: 8X15R84UEM)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    RHEUM OFFICINALE STEM (UNII: 82X32CRA5U)  
    CORYDALIS BUNGEANA WHOLE (UNII: 732H9A883V)  
    BLETILLA STRIATA WHOLE (UNII: WV2BSG60EW)  
    CELOSIA CRISTATA FLOWER (UNII: O8090YN80Y)  
    COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL)  
    AGRIMONIA PILOSA WHOLE (UNII: HFK6WFO04P)  
    PODOPHYLLUM RESIN (UNII: 16902YVY2B)  
    GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)  
    LYSOZYME, CHICKEN EGG WHITE (UNII: 1ZML031Y3C)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    SODIUM DIACETATE (UNII: 26WJH3CS0B)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    ROSE OIL (UNII: WUB68Y35M7)  
    JASMINUM SAMBAC FLOWER (UNII: 2S686I937F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68991-003-1010 in 1 PACKAGE05/20/2011
    13 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/20/2011
    Labeler - Shenzhen Senton Science & Technology Co. Ltd (421347623)
    Registrant - Shenzhen Senton Science & Technology Co. Ltd (421347623)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Senton Science & Technology Co. Ltd421347623manufacture(68991-003)