NDC 73000-225 Utimi Water Based Personal Lubricant

Personal Lubricant

NDC Product Code 73000-225

NDC Code: 73000-225

Proprietary Name: Utimi Water Based Personal Lubricant What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Personal Lubricant What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 73000 - Shenzhen Zhihuichuangxiang Technology Co., Ltd
    • 73000-225 - Utimi Water Based Personal Lubricant

NDC 73000-225-20

Package Description: 30 mL in 1 BOTTLE

NDC Product Information

Utimi Water Based Personal Lubricant with NDC 73000-225 is a a human over the counter drug product labeled by Shenzhen Zhihuichuangxiang Technology Co., Ltd. The generic name of Utimi Water Based Personal Lubricant is personal lubricant. The product's dosage form is lotion and is administered via rectal; vaginal form.

Labeler Name: Shenzhen Zhihuichuangxiang Technology Co., Ltd

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Utimi Water Based Personal Lubricant Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • HYDROXYETHYL CELLULOSE (140 CPS AT 5%) .381 g/30mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • WATER (UNII: 059QF0KO0R)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • LACTIC ACID, DL- (UNII: 3B8D35Y7S4)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Rectal - Administration to the rectum.
  • Vaginal - Administration into the vagina.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Shenzhen Zhihuichuangxiang Technology Co., Ltd
Labeler Code: 73000
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-27-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Utimi Water Based Personal Lubricant Product Label Images

Utimi Water Based Personal Lubricant Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Hydroxyethyl Cellulose

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.

* Please review the disclaimer below.

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