Label: EROS PLATINUM BODYGLIDE SUPER CONCENTRATED- dimethicone 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

    DIMETHICONE 30%

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  • PURPOSE

    SKIN PROTECTANT

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  • INDICATIONS & USAGE

    • HELPS LUBRICATING IN BODY MASSAGE
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  • INACTIVE INGREDIENT

    DIMETHICONOL, CYCLOMETHICONE, VINYL DIMETHICONE CROSSPOLYMER, CYCLOPENTASILOXANE

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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 TO CONDOMS. REAPPLY AS NEEDED. CLOSE CAP AFTER USE.
    • RINSE WITH WATER TO REMOVE.
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  • WARNINGS

    WARNINGS

    • FOR EXTERNAL USE ONLY
    • STOP USE AND ASK DOCTOR IF RASH OR IRRITATION DELOVELOPES AND LASTS.
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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

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  • INGREDIENTS AND APPEARANCE
    EROS PLATINUM BODYGLIDE  SUPER CONCENTRATED
    dimethicone gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53389-000
    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  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER  
    CYCLOMETHICONE 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53389-000-13 100 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 11/01/2012
    Labeler - MEGASOL COSMETIC GMBH (344152855)
    Establishment
    Name Address ID/FEI Business Operations
    MEGASOL COSMETIC GMBH 344152855 manufacture(53389-000)
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