ZEDOARY OILS FEMININE ANTIBACTERIAL GELS- chlorhexidine diacetate gel

ZEDOARY OILS FEMININE ANTIBACTERIAL GELS by

Drug Labeling and Warnings

ZEDOARY OILS 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]

SPL UNCLASSIFIED SECTION

ZEDOARY OIL 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

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

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

SOPHORA FLAVESCENS
STEMONA TUBEROSA
FRUCTUS CNIDII
ZEDOARY OIL
CARBOMER
PURIFIED WATER

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

ZEDOARY OILS FEMININE ANTIBACTERIAL GELS 
chlorhexidine diacetate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81615-002
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
ZEDOARY OIL (UNII: QPP5U30FSD)
OSTHOL (UNII: XH1TI1759C)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
STEMONA TUBEROSA ROOT (UNII: 7S9328671Z)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81615-002-02	7 in 1 BOX	03/16/2021
1	NDC: 81615-002-01	5 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 81615-002-04	10 in 1 BOX	03/16/2021
2	NDC: 81615-002-03	2 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 81615-002-06	10 in 1 BOX	03/16/2021
3	NDC: 81615-002-05	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

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(81615-002)