Label: SHUIFULAN HIGH-EFFICIENCY ANTI-BACTERIA MONOMER SILVER GEL FOR WOMEN- anti-bacteria monomer silver gel for women gel, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 69519-0101-1, 69519-0101-5 - Packager: SHUIFULAN (BEIJING) BIOLOGICAL TECHNOLOGY CO., LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated January 9, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
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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.
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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
- Stop use
- Ask doctor
- Ask doctor/pharmacist
- Keep out of reach of children
- Questions
- Pregnancy or breast feeding
- Indications & usage
- Dosage & administration
- Dosage forms & strengths
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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
- Inactive ingredient
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INGREDIENTS AND APPEARANCE
SHUIFULAN HIGH-EFFICIENCY ANTI-BACTERIA MONOMER SILVER GEL FOR WOMEN
anti-bacteria monomer silver gel for women gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69519-0101 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Silver (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) Silver 350 ug in 3 g Inactive Ingredients Ingredient Name Strength Carbomer 934 (UNII: Z135WT9208) 6 mg in 3 g Water (UNII: 059QF0KO0R) 293650 ug in 3 g Product Characteristics Color brown Score Shape FREEFORM Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69519-0101-5 12 in 1 BOX 01/09/2015 1 NDC:69519-0101-1 3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/09/2015 Labeler - SHUIFULAN (BEIJING) BIOLOGICAL TECHNOLOGY CO., LTD (544310624) Registrant - SHUIFULAN (BEIJING) BIOLOGICAL TECHNOLOGY CO., LTD (544310624) Establishment Name Address ID/FEI Business Operations SHUIFULAN (BEIJING) BIOLOGICAL TECHNOLOGY CO., LTD 544310624 manufacture(69519-0101) , label(69519-0101) , relabel(69519-0101)
