DERMA GLIDE- glycerin gel 
Pella Pharmaceuticals Co. Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Derma Glide Gel

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

Primary Package

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)

Revised: 6/2023
Document Id: fe26caf9-8287-cf5d-e053-6394a90a9acc
Set id: fe26caf9-8286-cf5d-e053-6394a90a9acc
Version: 1
Effective Time: 20230615
 
Pella Pharmaceuticals Co. Ltd