Label: UNDA 11- asparagus officinalis young shoot, mentha piperita whole plant, millefolium whole plant,thymus serpyllum whole plant, crocus sativus dried stigma, rosmarinus officinalis flowering twigs, glechoma hederacea whole plant, verbena officinalis whole plant, uva-ursi leaf, cuprum metallicum liquid
- NDC Code(s): 62106-1110-8
- Packager: Seroyal USA
- 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 November 8, 2022
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ACTIVE INGREDIENT
Active ingredients
Each drop contains:
Asparagus officinalis (Asparagus) Shoot 4X
Crocus sativus (Saffron) Dried Stigma 4X
Cuprum metallicum (Copper) 12X
Glechoma hederacea (Ground-ivy) Aerial Parts 4X
Mentha piperita Aerial Parts 4X
Millefolium (Yarrow) Aerial Parts 4X
Rosmarinus officinalis (Rosemary) Leaf 4X
Thymus serpyllum (Wild thyme) Aerial Parts 4X
Uva-ursi (Bearberry) Leaf 4X
Verbena officinalis (Common vervain) Aerial Parts 4X - PURPOSE
- WARNINGS
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UNDA 11
asparagus officinalis young shoot, mentha piperita whole plant, millefolium whole plant,thymus serpyllum whole plant, crocus sativus dried stigma, rosmarinus officinalis flowering twigs, glechoma hederacea whole plant, verbena officinalis whole plant, uva-ursi leaf, cuprum metallicum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1110 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VERBENA OFFICINALIS (UNII: QT8A71T9BM) (VERBENA OFFICINALIS - UNII:QT8A71T9BM) VERBENA OFFICINALIS 4 [hp_X] in 20 mL COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 12 [hp_X] in 20 mL ASPARAGUS (UNII: Z1EJP3037Z) (ASPARAGUS - UNII:Z1EJP3037Z) ASPARAGUS 4 [hp_X] in 20 mL GLECHOMA HEDERACEA (UNII: L6O7WQK912) (GLECHOMA HEDERACEA - UNII:L6O7WQK912) GLECHOMA HEDERACEA 4 [hp_X] in 20 mL ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) (ARCTOSTAPHYLOS UVA-URSI LEAF - UNII:3M5V3D1X36) ARCTOSTAPHYLOS UVA-URSI LEAF 4 [hp_X] in 20 mL MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9) MENTHA PIPERITA 4 [hp_X] in 20 mL ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM 4 [hp_X] in 20 mL THYMUS SERPYLLUM (UNII: 86H4S6K51N) (THYMUS SERPYLLUM - UNII:86H4S6K51N) THYMUS SERPYLLUM 4 [hp_X] in 20 mL SAFFRON (UNII: E849G4X5YJ) (SAFFRON - UNII:E849G4X5YJ) SAFFRON 4 [hp_X] in 20 mL ROSMARINUS OFFICINALIS FLOWERING TOP (UNII: 8JM482TI79) (ROSMARINUS OFFICINALIS FLOWERING TOP - UNII:8JM482TI79) ROSMARINUS OFFICINALIS FLOWERING TOP 4 [hp_X] in 20 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:62106-1110-8 1 in 1 CARTON 02/24/2015 1 20 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/24/2015 Labeler - Seroyal USA (018361118) Establishment Name Address ID/FEI Business Operations SAN’UP 401010287 manufacture(62106-1110)
