Label: UNDA 240- equisetum arvense, gentiana lutea, salvia officinalis, saxifraga granulata, spiraea ulmaria liquid
- NDC Code(s): 62106-1161-8
- 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 9, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
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INGREDIENTS AND APPEARANCE
UNDA 240
equisetum arvense, gentiana lutea, salvia officinalis, saxifraga granulata, spiraea ulmaria liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1161 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS) (FILIPENDULA ULMARIA ROOT - UNII:997724QNDS) FILIPENDULA ULMARIA ROOT 6 [hp_X] in 20 mL SAGE (UNII: 065C5D077J) (SAGE - UNII:065C5D077J) SAGE 6 [hp_X] in 20 mL GENTIANA LUTEA ROOT (UNII: S72O3284MS) (GENTIANA LUTEA ROOT - UNII:S72O3284MS) GENTIANA LUTEA ROOT 6 [hp_X] in 20 mL SAXIFRAGA GRANULATA FLOWERING TOP (UNII: G5005J3X2B) (SAXIFRAGA GRANULATA FLOWERING TOP - UNII:G5005J3X2B) SAXIFRAGA GRANULATA FLOWERING TOP 6 [hp_X] in 20 mL EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) (EQUISETUM ARVENSE BRANCH - UNII:1L0VKZ185E) EQUISETUM ARVENSE BRANCH 6 [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:62106-1161-8 1 in 1 CARTON 12/14/2016 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 12/14/2016 Labeler - Seroyal USA (018361118) Establishment Name Address ID/FEI Business Operations SAN’UP 401010287 manufacture(62106-1161)