NDC 73194-212 Acmeros Lubricant X0026f3541

Personal Lubricant

NDC Product Code 73194-212

NDC Code: 73194-212

Proprietary Name: Acmeros Lubricant X0026f3541 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

  • 73194 - Shenzhen Yuqintang Shengwu Jishu Co., Ltd.
    • 73194-212 - Acmeros Lubricant X0026f3541

NDC 73194-212-61

Package Description: 236 mL in 1 BOTTLE

NDC Product Information

Acmeros Lubricant X0026f3541 with NDC 73194-212 is a a human over the counter drug product labeled by Shenzhen Yuqintang Shengwu Jishu Co., Ltd.. The generic name of Acmeros Lubricant X0026f3541 is personal lubricant. The product's dosage form is oil and is administered via cutaneous; extracorporeal; topical; vaginal form.

Labeler Name: Shenzhen Yuqintang Shengwu Jishu Co., Ltd.

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

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.

Acmeros Lubricant X0026f3541 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.

  • BUTYLENE GLYCOL 47.2 g/236mL

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.

  • ALOIN (UNII: W41H6S09F4)
  • HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) (UNII: 12VCE9HR9E)
  • WATER (UNII: 059QF0KO0R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYETHYLENE GLYCOL 300000 (UNII: 4QIB4U4CQR)
  • CHLORPHENESIN (UNII: I670DAL4SZ)

Administration Route(s)

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

  • Cutaneous - Administration to the skin.
  • Extracorporeal - Administration outside of the body.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • 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 Yuqintang Shengwu Jishu Co., Ltd.
Labeler Code: 73194
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: 06-25-2019 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.

Acmeros Lubricant X0026f3541 Product Label Images

Acmeros Lubricant X0026f3541 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

Butylene glycol (20%): 47.2g(mL)/package

Inactive Ingredient

Inactive ingredient:water (67.52%): 159.3472mL/packagealoe extract (10%): 23.6mL/packagehydroxyethylcellulose (1.6%): 3.776mL/packagepolyethylene glycol 300000 (0.5%): 1.18mL/packagephenoxyethanol (0.3%): 0.708mL/packagechlorphenesin (0.08%): 0.1888mL/package

Purpose

This lubricant is made from high quality raw materials.It can achieve higher lubricantion, longer lubrication time and less dosage.

When Using

Virginal dryness and/or intimate sexual activity.

Do Not Use

Do not use when wound or skin infection.

Stop Use

If irritation or discomfort occurs, discontinue use and see a doctor.

Very slippery on surfaces, clean spills immediately.

Ask Doctor

If irritation or discomfort occurs, discontinue use and see a doctor.

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 pets.

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 product is a water-based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity, help relieve virginal dryness, and supplement to the body's natural lubricant.Apply a small amount to genital areas. Reapply as needed or desired.

Dosage & Administration

One bottle of 236mL in one bottle/package.Apply a small amount to the area of the body you wish to lubricate.

Dosage Forms & Strengths

The lubricant is like oil form. Strengths: 20%.A small amount one time, or reapply as needed or desired.

Warnings

If irritation or discomfort occurs, discontinue use and see a doctor.

This is not a contraceptive or spermicide.
Keep out of reach of children and pets.

Keep out of eyes and ears.

* Please review the disclaimer below.

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