Label: CALENDULA 3X liquid
- NDC Code(s): 48951-3247-1
- Packager: Uriel Pharmacy 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 July 13, 2021
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.
REFRIGERATE AFTER OPENING.
USE WITHIN 30 DAYS OF OPENING.
Opened on_________________ - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CALENDULA 3X
calendula 3x liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-3247 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM CHLORIDE (UNII: 451W47IQ8X) ROSE OIL (UNII: WUB68Y35M7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48951-3247-1 1 in 1 BAG 09/01/2009 1 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/01/2009 Labeler - Uriel Pharmacy Inc. (043471163) Establishment Name Address ID/FEI Business Operations Uriel Pharmacy Inc. 043471163 manufacture(48951-3247)
