MOTHERWORT HERB FEMININE ANTIBACTERIAL GEL

MOTHERWORT HERB FEMININE ANTIBACTERIAL GELS by

Drug Labeling and Warnings

MOTHERWORT HERB FEMININE ANTIBACTERIAL GELS 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]

MOTHERWORT HERB FEMININE ANTIBACTERIAL GELS- chlorhexidine diacetate 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.

----------

MOTHERWORT HERB FEMININE ANTIBACTERIAL GEL

MOTHERWORT HERB FEMININE ANTIBACTERIAL GEL

Active Ingredient(s)

CHLORHEXIDINE DIACETATE 0.09g/100g

Purpose

BACTERIOSTATIC

Use

Uses for female daily intimate internal & external cleaning and hygiene care.

Warnings

Disposable product. Please do not use if the package is broken.

This product is for external use only, not edible.

Avoid contact with eyes

This product cannot be used for STD prevention in sexual activity.

Women who are in menstrual, gestational or perinatal periods should be used with extreme caution.

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

1.Take a supine position, and support the hip with a cushion. Remove the socket at the top of the injector and use it as the plunger rod. Slowly insert the gel injector containing antibacterial gel into the deep area of vagina. Deliver the gel into the vagina by pushing the plunger.
2.If there is discomfort in the intimate area, squeeze a little of the gel and apply onto the area, then gently rub for a while.
3.While in use, it’s normal to see vaginal discharge, so it’s recommended to use panty liners meanwhile.
4.Better effect can be obtained if FUYANJIE WASH is used before applying this product.

Other information

This product can sterilize staphylococcus aureus, Escherichia coli, and Candida albicans.

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

Inactive ingredients

MOTHERWORT HERB
SOPHORA FLAVESCENS
STEMONA TUBEROSA
FRUCTUS CNIDII
CORTEX PHELLODENDRI
CARBOMER
PURIFIED WATER

Package Label - Principal Display Panel

MOTHERWORT HERB FEMININE ANTIBACTERIAL GELS 
chlorhexidine diacetate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81615-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE ACETATE	0.09 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OSTHOL (UNII: XH1TI1759C)
LEONURUS CARDIACA FLOWERING TOP (UNII: IJ4SXX96Y4)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PHELLODENDRON CHINENSE WHOLE (UNII: QKA3ZK8IIE)
STEMONA TUBEROSA ROOT (UNII: 7S9328671Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81615-004-02	7 in 1 BOX	03/16/2021
1	NDC: 81615-004-01	5 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 81615-004-04	10 in 1 BOX	03/16/2021
2	NDC: 81615-004-03	2 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 81615-004-06	10 in 1 BOX	03/16/2021
3	NDC: 81615-004-05	3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/16/2021	04/07/2021

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(81615-004)

Revised: 4/2021

Document Id: bf60582d-2ca4-b60f-e053-2a95a90a16ac

34390-5

Set id: bda6a464-4115-75b2-e053-2995a90ad5d5

Version: 3

Effective Time: 20210407

 

Jiangxi