Active Ingredient
Hydroxyethyl Cellulose
Utimi Water Based Personal Lubricant
FDA Label NDC 73000-225
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Zhihuichuangxiang Technology Co., Ltd for the product Utimi Water Based Personal Lubricant (NDC 73000-225). 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 active ingredient, inactive ingredient, purpose, when using, do not use, stop use, ask doctor, ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
De-lonized Water
Glycerin
Propylene Glycol
Sodium Benzoate
Polysorbate 20
Disodium EDTA
Lactic Acid
Purpose
Utimi Personal Lubricant is a water-based lubricant for penile or vaginal application, intended to moisturize and enhance the ease and comfort of intimate sexual activity as well as supplement for the body's natural lubrication.
This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.
When Using
Virginal / Anal dryness and/or intimate sexual activity.
This product is not a contraceptive and does not contain a spermicide.
Do Not Use
Do not use when wound or skin infection.
It should be cautiously used if you are kind of allergic constitution or you have inflammation.
Do not use if quality seal on the opening of the container is broken or missing.
Do not use if tamper-evident seal is removed or broken.
Stop Use
If irritation or discomfort occurs, discontinue the use and consult a physician.
Very slippery on surfaces, clean spills immediately.
Ask Doctor
If irritation or discomfort occurs, discontinue the use and consult a physician.
Ask Doctor/Pharmacist
Ask doctor/pharmacist when you current use other drugs.
Keep Out Of Reach Of Children
Keep out of reach of children and away from eyes and ears.
Questions
Please contact us when you have any questions.
Pregnancy Or Breast Feeding
Pregnant or breast feeding women shall follow doctor advice.
Indications & Usage
This is a water-based lubricant for penile or vaginal application, intended to moisturize and enhance the ease and comfort of intimate sexual activity as well as supplement for the body's natural lubrication.
Apply a small amount to genital areas. Reapply as needed or desired.
Dosage & Administration
Apply a small amount to genital areas. Reapply as needed or desired.
Dosage Forms & Strengths
The lubricant is like oil form.
One capsule (0.9g lubricant and 0.3g gelatin coated) once time.
The active ingredient strength is 0.324g.
Warnings
If irritation or discomfort occurs, pleas discontinue to use and consult a physician.
Very slippery surfaces, clean the spills immediately.
This product is not a contraceptive or spermicide.
Keep out of children and pets' reach.
Package Label. Principal Display Panel
As attached.
* Please review the disclaimer below.
