Label: DERMA GLIDE- glycerin gel

  • NDC Code(s): 82160-641-01
  • Packager: Pella Pharmaceuticals Co. Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated June 15, 2023

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  • Forms and Presentation

    Gel: Tube, 75 g

  • Active Ingredients

    Glycerin

  • Inactive Ingredients

    Aqua, Propylene Glycol, Hydroxyethylcellulose, Phenoxyethanol, Ethylhexylglycerin, Citric Acid.

  • Purpose

    Personal Lubricant

  • Properties

    Derma Glide gel is gentle, transparent, greaseless water based gel, matches the pH of the vagina.

    Does not contain fragrances, colorant, parabens, and silicone oils.

  • Indication

    Derma Glide gel is a personal lubricant for him and her to apply it onto intimate areas, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.

  • Precuations

    Keep out of reach of children

  • Warnings

    - For topical use only.
    - Avoid contact with the eyes.
    - If discomfort or irritation or discomfort occurs, discontinue use immediately and consult a physician.
    - In case of vaginal infection, consult your doctor before use.
    - If you are pregnant consult your doctor before use.
    - This Product is not a spermicide and cannot be used as a contraceptive, but it may slow sperm down, so if you are trying to have a baby, talk to your doctor before use.
    - Very slippery on surfaces, clean spills immediately.

  • Contraindication

    Hypersensitivity to any of the components

  • Side Effects

    There are no known side effects

  • Dosage and Administration

    Remove seal from tube opening before initial use. Apply sufficient amount to intimate areas. Reapply as needed. To enhance condom use, add a small amount to the inner and outer surfaces. Wash off after use.

  • Storage Conditions

    Store below 30 ◦C

  • PRINCIPAL DISPLAY PANEL

    Primary Package

  • INGREDIENTS AND APPEARANCE
    DERMA GLIDE 
    glycerin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82160-641
    Route of AdministrationVAGINAL, RECTAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82160-641-0175 g in 1 TUBE; Type 0: Not a Combination Product05/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/31/2022
    Labeler - Pella Pharmaceuticals Co. Ltd (562370925)
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