Label: UNDA 270- calendula officinalis, dulcamara, equisetum arvense, hypericum perforatum liquid
- NDC Code(s): 62106-1166-8
- 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 July 15, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
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INDICATIONS & USAGE
Uses
For the temporary relief of symptoms associated with
minor skin irritation
occasional headacheDirections
Adults and adolescents (12 years and older)Take 5 drops three times daily or as recommended by your healthcare practitioner.
Children (under 12 years)
Take under the direction of your healthcare practitioner.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UNDA 270
calendula officinalis, dulcamara, equisetum arvense, hypericum perforatum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1166 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOLANUM DULCAMARA STEM (UNII: IR986LE7DF) (SOLANUM DULCAMARA STEM - UNII:IR986LE7DF) SOLANUM DULCAMARA STEM 4 [hp_X] in 20 mL CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 4 [hp_X] in 20 mL EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) (EQUISETUM ARVENSE BRANCH - UNII:1L0VKZ185E) EQUISETUM ARVENSE BRANCH 4 [hp_X] in 20 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 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:62106-1166-8 1 in 1 CARTON 10/17/2017 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 10/17/2017 Labeler - Seroyal USA (018361118) Establishment Name Address ID/FEI Business Operations SAN’UP 401010287 manufacture(62106-1166)