FDA.reportPublic FDA data

PERSONAL LUBRICANT

Manufacturer
Jiangxi Renhetang pharmaceutical chain Co., Ltd. | Jiangxi Kangmei medical and Health Products Co., Ltd
Effective date
2021-04-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:39:49

Label at a glance#

ProductPERSONAL LUBRICANT
Active ingredientHYALURONATE SODIUM
Label structure12 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

PERSONAL LUBRICANT

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

SODIUM HYALURONATE 0.01g/100mL

Purpose

OTC - PURPOSE SECTION

BACTERIOSTATIC

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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 SECTION

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 SECTION

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 SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

112233

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81615-001-012022-07-29C16284748780-1e4f33bdf-9e96-d8a0-e053-dadaa90a6e4ePERSONAL LUBRICANT
81615-001-022022-07-29C16284748780-1e4f33bdf-9e96-d8a0-e053-dadaa90a6e4ePERSONAL LUBRICANT
81615-001-032022-07-29C16284748780-1e4f33bdf-9e96-d8a0-e053-dadaa90a6e4ePERSONAL LUBRICANT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81615-001-01PERSONAL LUBRICANT60 mL in 1 BOTTLEGEL605
81615-001-02PERSONAL LUBRICANT80 mL in 1 BOTTLEGEL805
81615-001-03PERSONAL LUBRICANT120 mL in 1 BOTTLEGEL1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81615-001PERSONAL LUBRICANT (SODIUM HYALURONATE) GEL [JIANGXI RENHETANG PHARMACEUTICAL CHAIN CO., LTD.]5Legacy NDC, 3 package rows20210421_bda4df53-00f4-7b00-e053-2a95a90a4227.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81615-00181615-001-01, 81615-001-02, 81615-001-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
POWDERED CELLULOSESMD1X3XO9MIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
HYALURONATE SODIUMYSE9PPT4THACTIB
ETHYL SALICYLATE555U6TZ2MVIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c067aaa1-dbbe-a528-e053-2a95a90aebaebda4df53-00f4-7b00-e053-2a95a90a42272021-04-20WarningsExact identifier
spl id: c067aaa1-dbbe-a528-e053-2a95a90aebae
spl set id: bda4df53-00f4-7b00-e053-2a95a90a4227

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.