SHUIFULAN HIGH-EFFICIENCY ANTI-BACTERIA MONOMER SILVER GEL FOR WOMEN- anti-bacteria monomer silver gel for women gel, dentifrice

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Silver (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G)
Available from:
SHUIFULAN (BEIJING) BIOLOGICAL TECHNOLOGY CO., LTD
Administration route:
VAGINAL
Prescription type:
OTC DRUG
Therapeutic indications:
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. 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 when finding any unpleasant symptoms. 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.
Authorization status:
unapproved homeopathic
Authorization number:
69519-0101-1, 69519-0101-5

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

Purpos e

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.

Ques tions

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

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 519 -0 10 1

Route of Administration

VAGINAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Silver (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G)

S ilve r

350 ug in 3 g

Inactive Ingredients

Ingredient Name

Stre ng th

Ca rbo mer 9 3 4 (UNII: Z135WT9 20 8 )

6 mg in 3 g

Wa ter (UNII: 0 59 QF0 KO0 R)

29 36 50 ug in 3 g

Product Characteristics

Color

bro wn

S core

S hap e

FREEFORM

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 519 -0 10 1-5

12 in 1 BOX

0 1/0 9 /20 15

1

NDC:6 9 519 -0 10 1-1

3 g in 1 TUBE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 1/0 9 /20 15

Labeler -

SHUIFULAN (BEIJING) BIOLOGICAL T ECHNOLOGY CO., LT D (544310624)

Registrant -

SHUIFULAN (BEIJING) BIOLOGICAL T ECHNOLOGY CO., LT D (544310624)

SHUIFULAN (BEIJING) BIOLOGICAL TECHNOLOGY CO., LTD

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

SHUIFULAN (BEIJING) BIOLOGICAL TECHNOLOGY

CO., LTD

544310 6 24

manufacture(6 9 519 -0 10 1) , label(6 9 519 -0 10 1) ,

re la be l(6 9 519 -0 10 1)

Revised: 1/2015

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