Label: EROS ANAL EASE- dimethicone spray 

  • 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

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    GLYCERIN 5%

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  • PURPOSE

    PURPOSE

    SKIN PROTECTANT

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  • INDICATIONS & USAGE

    USES

    • Protects skin from irritation.
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  • WARNINGS

    Warning:

    • For external use only.
    • Use only in the anal region.
    • Avoid contact with eyes.
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  • KEEP OUT OF REACH OF CHILDREN

    • KEEP OUT OF REACH OF CHILDREN
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  • DOSAGE & ADMINISTRATION

    Directions for use:

    • Apply 1 or 2 sprays to the anus and allow a short time to take effect.
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  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, laureth-9, Peg-6, caprylic/capric glycerides, menthyl lactate, lactic acid, sodium benzoate, potassium sorbate.

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  • INGREDIENTS AND APPEARANCE
    EROS ANAL EASE 
    glycerin spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53389-046
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (DIMETHICONE) DIMETHICONE 30 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    DIMETHICONOL (100000 CST)  
    CYCLOMETHICONE 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53389-046-22 50 mL in 1 BOTTLE, SPRAY
    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(53389-046)
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