PERSONAL LUBRICANT- sodium hyaluronate gel

PERSONAL LUBRICANT by

Drug Labeling and Warnings

PERSONAL LUBRICANT by is a Otc medication manufactured, distributed, or labeled by Jiangxi Renhetang pharmaceutical chain Co., Ltd., Jiangxi Kangmei medical and Health Products Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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

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

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 SERUM.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

PERSONAL LUBRICANT 
sodium hyaluronate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81615-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY)	HYALURONATE SODIUM	0.01 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81615-001-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/2021
2	NDC: 81615-001-02	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/2021
3	NDC: 81615-001-03	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/16/2021

Labeler - Jiangxi Renhetang pharmaceutical chain Co., Ltd. (410551226)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Kangmei medical and Health Products Co., Ltd		528118770	manufacture(81615-001)