Label: M EROS LIQUID AQUA BASED- glycerin gel 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    GLYCERIN 5%

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  • PURPOSE

    PURPOSE

    SKIN PROTECTANT

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  • INDICATIONS & USAGE

    USES

    HELPS LUBRICATING IN BODY MASSAGE

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  • WARNINGS

    WARNINGS

    • FOR EXTERNAL USE ONLY
    • STOP AND ASK DOCTOR IF RASH OR IRRATION DEVELOPES AND LASTS.
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  • DOSAGE & ADMINISTRATION

    DIRECTIONS FOR USE

    • APPLY AS NEEDED
    • OPEN CAP, SQUEEZE TUBE TO OBTAIN DESIRED AMOUNT OF LUBRICANT. MAY BE APPLIED DIRECTLY ONTO CONDOMS. REAPPLY AS NEEDED. CLOSE CAP AFTER USE.
    • RINSE WITH WATER TO REMOVE.

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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    • WATER
    • HYDROXYPROPYL GUAR
    • HYDROXYPROPYLTRIMONIUM CLORIDE
    • HYDROXYETHYLCELLULOSE
    • CITRIC ACIS
    • PHENOXYETHANOL
    • ETHYLHEXLGLYCERIN
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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

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  • INGREDIENTS AND APPEARANCE
    M EROS LIQUID  AQUA BASED
    glycerin gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53389-600
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GLYCERIN (GLYCERIN) GLYCERIN 5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%)  
    DIHYDROXYPROPYLTRIMONIUM CHLORIDE  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)  
    ANHYDROUS CITRIC ACID  
    PHENOXYETHANOL  
    ETHYLHEXYLGLYCERIN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53389-600-14 250 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 12/01/2012
    Labeler - MEGASOL COSMETIC GMBH (344152855)
    Establishment
    Name Address ID/FEI Business Operations
    MEGASOL COSMETIC GMBH 344152855 manufacture(53389-600)
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