NDC 81615-001 Personal Lubricant

Sodium Hyaluronate

NDC Product Code 81615-001

NDC 81615-001-01

Package Description: 60 mL in 1 BOTTLE

NDC 81615-001-02

Package Description: 80 mL in 1 BOTTLE

NDC 81615-001-03

Package Description: 120 mL in 1 BOTTLE

NDC Product Information

Personal Lubricant with NDC 81615-001 is a a human over the counter drug product labeled by Jiangxi Renhetang Pharmaceutical Chain Co., Ltd.. The generic name of Personal Lubricant is sodium hyaluronate. The product's dosage form is gel and is administered via topical form.

Labeler Name: Jiangxi Renhetang Pharmaceutical Chain Co., Ltd.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

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.

  • HYALURONATE SODIUM .01 g/100mL

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • POWDERED CELLULOSE (UNII: SMD1X3XO9M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • ETHYL SALICYLATE (UNII: 555U6TZ2MV)

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Jiangxi Renhetang Pharmaceutical Chain Co., Ltd.
Labeler Code: 81615
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: 03-16-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Personal Lubricant Product Label Images

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

Other

PERSONAL LUBRICANT

Active Ingredient(S)

SODIUM HYALURONATE 0.01g/100mL

Purpose

BACTERIOSTATIC

Use

Uses for adult sexual wellness, which can produce lubrication to facilisexual activity.

Warnings

This product cannot be used as spermicide or contraceptives. Please keep this product out of the reach of children. Discontinue use should any allergy occur.

Otc - When Using

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Squeeze out the product and apply desired amount onto the intimate area. Reapply as desired. It can be used for vaginal sex, oral sex, anal sex, etc.

Other Information

  • Keep in sealed container, and place in a cool dry place.

Inactive Ingredients

WATER, GLYCEROL, PROPYLENE GLYCOL, CELLULOSE, SODIUM HYALURONATE, ETHYL 2-HYDROXYBENZOATE, ALOE SERUMl.

* Please review the disclaimer below.