Label: EROS AQUA - glycerin gel 

  • 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 11/12

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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

    WARNING:

    • FOR EXTERNAL USE ONLY
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  • KEEP OUT OF REACH OF CHILDREN

    • KEEP OUT OF REACH OF CHILDREN
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  • STOP USE

    • STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS.
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  • DOSAGE & ADMINISTRATION

    DIRECTIONS FOR USE:

    • APPLY AS NEEDED
    • OPEN THE 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 CHLORIDE, HYDROXYETHYLCELLULOSE, CITRIC ACID, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN.

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  • INGREDIENTS AND APPEARANCE
    EROS AQUA 
    glycerin gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53389-331
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GLYCERIN (GLYCERIN) GLYCERIN 30 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW)  
    ANHYDROUS CITRIC ACID  
    PHENOXYETHANOL  
    ETHYLHEXYLGLYCERIN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53389-331-13 100 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 10/01/2012
    Labeler - MEGASOL COSMETIC GMBH (344152855)
    Establishment
    Name Address ID/FEI Business Operations
    MEGASOL COSMETIC GMBH 344152855 manufacture(53389-331)
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