PERSONAL LUBRICANT- sodium hyaluronate gel 
Jiangxi Renhetang pharmaceutical chain Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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PERSONAL LUBRICANT

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.

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.

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.

Directions

Other information

Inactive ingredients

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

Package Label - Principal Display Panel

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PERSONAL LUBRICANT 
sodium hyaluronate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81615-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM0.01 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
ETHYL SALICYLATE (UNII: 555U6TZ2MV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81615-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/2021
2NDC:81615-001-0280 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/2021
3NDC:81615-001-03120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/16/2021
Labeler - Jiangxi Renhetang pharmaceutical chain Co., Ltd. (410551226)
Establishment
NameAddressID/FEIBusiness Operations
Jiangxi Kangmei medical and Health Products Co., Ltd528118770manufacture(81615-001)

Revised: 4/2021
Document Id: c067aaa1-dbbe-a528-e053-2a95a90aebae
Set id: bda4df53-00f4-7b00-e053-2a95a90a4227
Version: 5
Effective Time: 20210420
 
Jiangxi Renhetang pharmaceutical chain Co., Ltd.