ZEDOARY OILS 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.

----------

ZEDOARY OIL FEMININE ANTIBACTERIAL GEL

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 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

SOPHORA FLAVESCENS
STEMONA TUBEROSA
FRUCTUS CNIDII
ZEDOARY OIL
CARBOMER
PURIFIED WATER

Package Label - Principal Display Panel

123

ZEDOARY OILS FEMININE ANTIBACTERIAL GELS 
chlorhexidine diacetate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81615-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE ACETATE0.09 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81615-002-027 in 1 BOX03/16/2021
1NDC:81615-002-015 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:81615-002-0410 in 1 BOX03/16/2021
2NDC:81615-002-032 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:81615-002-0610 in 1 BOX03/16/2021
3NDC:81615-002-053 g in 1 TUBE; Type 0: Not a Combination Product
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(81615-002)

Revised: 4/2021
Document Id: c067618d-05de-0818-e053-2a95a90af9f1
Set id: bda5de82-58a1-86f9-e053-2995a90af5aa
Version: 3
Effective Time: 20210420
 
Jiangxi Renhetang pharmaceutical chain Co., Ltd.