Label: BANDA-SIL GEL SILVER WOUND DRESSING- argentum metallucum gel
- NDC Code(s): 72363-004-01, 72363-004-03
- Packager: AG Essence Inc
- 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 April 19, 2024
If you are a consumer or patient please visit this version.
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DOSAGE & ADMINISTRATION
Directions:
Clean wound area of dirt and debris. Apply a layer of hydrogel to the affected area. Cover with a sterile gauze or appropriate secondary dressing and secure in place. Banda-Sil Silver Wound Gel may be left in place for up to 3 days. Change more frequently depending on wound drainage.
Indications for use:
For relief of symptoms due to wounds, burns, scrapes, ulcerations or minor infections.
Disclaimer: These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease. - WARNINGS
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- ACTIVE INGREDIENT
- Banda-Sil Silver Wound Gel Box
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INGREDIENTS AND APPEARANCE
BANDA-SIL GEL SILVER WOUND DRESSING
argentum metallucum gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72363-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER 1 g in 21.5 g Inactive Ingredients Ingredient Name Strength ARGININE (UNII: 94ZLA3W45F) 0.215 g in 21.5 g WATER (UNII: 059QF0KO0R) 16.835 g in 21.5 g POLYQUATERNIUM-4 (1600 MPA.S AT 2%) (UNII: YE8J8372VI) 1.5 g in 21.5 g GLYCERIN (UNII: PDC6A3C0OX) 1.95 g in 21.5 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72363-004-03 1 in 1 BOX 06/30/2021 1 NDC:72363-004-01 21.5 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 homeopathic 06/25/2021 Labeler - AG Essence Inc (068562165) Establishment Name Address ID/FEI Business Operations AG Essence Inc. 068562165 manufacture(72363-004)
