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Product NDC Code | 82160-641 | ||||
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Drug Name | Derma glide |
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Type | Brand | ||||
Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC] |
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Active Ingredients |
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Route | RECTAL, TOPICAL, VAGINAL | ||||
Dosage Form | GEL | ||||
Labeler Name | Pella Pharmaceuticals Co. Ltd | ||||
Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Side Effects There are no known side effects
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Glycerin
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.Contraindication Hypersensitivity to any of the components
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.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.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aqua, Propylene Glycol, Hydroxyethylcellulose, Phenoxyethanol, Ethylhexylglycerin, Citric Acid.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Purpose
Information about the drug product’s indications for use.Purpose Personal Lubricant
Spl product data elements
Usually a list of ingredients in a drug product.Derma Glide Glycerin ETHYLHEXYLGLYCERIN PHENOXYETHANOL PROPYLENE GLYCOL HYDROXYETHYL CELLULOSE, UNSPECIFIED WATER GLYCERIN GLYCERIN CITRIC ACID MONOHYDRATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Primary Package
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Precuations Keep out of reach of children
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.Forms and Presentation Gel: Tube, 75 g
Storage and handling
Information about safe storage and handling of the drug product.Storage Conditions Store below 30 ◦ C
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API