SHUIFULAN HIGH-EFFICIENCY ANTI-BACTERIA MONOMER SILVER GEL FOR WOMEN- anti-bacteria monomer silver gel for women gel, dentifrice 
SHUIFULAN (BEIJING) BIOLOGICAL TECHNOLOGY CO., LTD

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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SHUIFULAN GEL

Active ingredient

Silver content: 350 μg/g; 4200 μg/package

Purpose

Anti-Bacteria

Monomer silver gel is a highly active agent which significantly suppresses and eliminates Candida albicans, Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa within and around the vagina, prevents and cures inflammation, accelerates the recovery of wounds and lesioned tissues regardless of vagina pH without affecting normal vaginal bacteria.

When using

Indication to bacterial vaginal diseases; vaginal candida infection; cervicitis; pruritus; abnormal vaginal discharge, or unpleasant smell due to vaginitis.

Topical use: Apply on the affected area of vagina.

For bacterial vaginitis and candida infection, 1 package each day, for 7 consecutive days, or longer if serious.

For cervicitis, 1 package each day, for 9 consecutive days, or longer if serious.

Do not use

Do not use if allergic to silver.

And it is not for virgins.

Notes:

1, Pregnant women or women in period avoid application in deep part of vagina.

2, Do not use if package is broken; do not use with medicine that contains Vaseline, chlorine, iodine or hydrogen peroxide.

Stop use

Stop use when finding any unpleasant symptoms.

Ask doctor

Ask doctor before you sure it is safe to your body.

Ask doctor/pharmacist

Ask doctor/pharmacist when you current use other drugs.

Keep out of reach of children

Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

Questions

Please contact us when you have any questions.

Pregnancy or breast feeding

Pregnant or breast feeding women shall follow doctor advice.

Indications & usage

Indication to bacterial vaginal diseases; vaginal candida infection; cervicitis; pruritus; abnormal vaginal discharge, or unpleasant smell due to vaginitis.

Topical use: Apply on the affected area of vagina.

Dosage & administration

For bacterial vaginitis and candida infection, 1 package each day, for 7 consecutive days, or longer if serious.
For cervicitis, 1 package each day, for 9 consecutive days, or longer if serious.

Dosage forms & strengths

Dosage form is Gel

Strengths is 3g(3mL)/tube

Warnings and precautions

Contraindications:

1, For external use only.

2, Not for virgins.

3, Do not use if allergic to silver.

4, Pregnant women shall follow doctor advice.

Notes:

1, Pregnant women or women in period avoid application in deep part of vagina.

2, Do not use if package is broken; do not use with medicine that contains Vaseline, chlorine, iodine or hydrogen peroxide.

3, This product is for external use only; do not take in. The gel may change in color, which is normal and has no impact on its effects.

4, Keep away from clothes to prevent contamination. Sanitary napkin is recommended to absorb the fluid of gel from vagina.

Package label. Principal display panel

Container Label

Container Label

Package Label

Package Label

Inactive ingredient

Carbomer 934 content: 6 mg/g; 72 mg/package

Water content: 293650 μg/g; 3523800 μg/package

SHUIFULAN HIGH-EFFICIENCY ANTI-BACTERIA MONOMER SILVER GEL FOR WOMEN 
anti-bacteria monomer silver gel for women gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69519-0101
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Silver (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) Silver350 ug  in 3 g
Inactive Ingredients
Ingredient NameStrength
Carbomer 934 (UNII: Z135WT9208) 6 mg  in 3 g
Water (UNII: 059QF0KO0R) 293650 ug  in 3 g
Product Characteristics
ColorbrownScore    
ShapeFREEFORMSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69519-0101-512 in 1 BOX01/09/2015
1NDC:69519-0101-13 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/09/2015
Labeler - SHUIFULAN (BEIJING) BIOLOGICAL TECHNOLOGY CO., LTD (544310624)
Registrant - SHUIFULAN (BEIJING) BIOLOGICAL TECHNOLOGY CO., LTD (544310624)
Establishment
NameAddressID/FEIBusiness Operations
SHUIFULAN (BEIJING) BIOLOGICAL TECHNOLOGY CO., LTD544310624manufacture(69519-0101) , label(69519-0101) , relabel(69519-0101)

Revised: 1/2015
Document Id: 752b54dc-4ab9-46b2-b10c-4fcc07e09876
Set id: 5512c68c-f98b-40bc-908e-3b9832721ecc
Version: 1
Effective Time: 20150109
 
SHUIFULAN (BEIJING) BIOLOGICAL TECHNOLOGY CO., LTD