Label: CATEGORY IV- immune system booster liquid
- NDC Code(s): 64616-085-02
- Packager: Vitality Works, 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 December 28, 2023
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- Category IV
- Category IV
- Category IV
- Category IV
- Category IV
- Category IV
- Category IV
- Category IV
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INGREDIENTS AND APPEARANCE
CATEGORY IV
immune system booster liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64616-085 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0) ACTAEA SPICATA ROOT 6 [hp_X] in 1 mL ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE 7 [hp_X] in 1 mL LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA 7 [hp_X] in 1 mL CUPRIC ARSENITE (UNII: SK8L60BCSQ) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC ARSENITE 15 [hp_X] in 1 mL COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 10 [hp_X] in 1 mL SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP 5 [hp_X] in 1 mL SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A) SKIM MILK 20 [hp_X] in 1 mL FRAXINUS AMERICANA BARK (UNII: 0B24UR1O1S) (FRAXINUS AMERICANA BARK - UNII:0B24UR1O1S) FRAXINUS AMERICANA BARK 8 [hp_X] in 1 mL URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS 5 [hp_X] in 1 mL ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 20 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64616-085-02 59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 03/20/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/20/2013 Labeler - Vitality Works, Inc. (137752817) Registrant - Vitality Works, Inc. (137752817) Establishment Name Address ID/FEI Business Operations Vitality Works, Inc. 137752817 manufacture(64616-085)