Forms And Presentation
Gel: Tube, 75 g
Derma Glide
FDA Label NDC 82160-641
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pella Pharmaceuticals Co. Ltd for the product Derma Glide (NDC 82160-641). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding forms and presentation, active ingredients, inactive ingredients, purpose, properties, indication, precuations, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
* Please review the disclaimer below.
