Label: ECHINACEA CALENDULA gel
- NDC Code(s): 48951-4164-5
- 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 March 9, 2021
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- Official Label (Printer Friendly)
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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ACTIVE INGREDIENT
Active Ingredients: 100gm contains: 30gm Echinacea (Purple coneflower) 1X, 15gm Calendula 1X, 0.5gm Resina laricis (Larch resin) 1X; Viscum Mali (Apple tree mistletoe) 3X, Cuprum aceticum (Copper acetate) 6X, Argentum metallicum (Silver) 7X, Cutis - feti (Porcine skin) 8X, Funiculus umbilicalis (Bovine umbilical cord) 8X, Placenta - bovis (Bovine placenta) 12X
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
Warnings: FOR EXTERNAL USE ONLY.
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Contains traces of lactose. Consult a doctor before use for serious conditions, if conditions worsen or persist, or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seal is broken or missing. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ECHINACEA CALENDULA
echinacea calendula gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-4164 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 1 [hp_X] in 1 g CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X] in 1 g LARIX DECIDUA RESIN (UNII: AD8LJ73GQF) (LARIX DECIDUA RESIN - UNII:AD8LJ73GQF) LARIX DECIDUA RESIN 1 [hp_X] in 1 g SUS SCROFA SKIN (UNII: 3EM4VW6TQN) (SUS SCROFA SKIN - UNII:3EM4VW6TQN) SUS SCROFA SKIN 8 [hp_X] in 1 g VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP) VISCUM ALBUM FRUITING TOP 3 [hp_X] in 1 g SUS SCROFA UMBILICAL CORD (UNII: 118OYG6W3H) (SUS SCROFA UMBILICAL CORD - UNII:118OYG6W3H) SUS SCROFA UMBILICAL CORD 8 [hp_X] in 1 g BOS TAURUS PLACENTA (UNII: 83AL37E3A7) (BOS TAURUS PLACENTA - UNII:83AL37E3A7) BOS TAURUS PLACENTA 12 [hp_X] in 1 g CUPRIC ACETATE (UNII: 39M11XPH03) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC ACETATE 6 [hp_X] in 1 g SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER 7 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) BORIC ACID (UNII: R57ZHV85D4) SODIUM ALGINATE (UNII: C269C4G2ZQ) SORBIC ACID (UNII: X045WJ989B) CITRUS PARADISI SEED (UNII: 12F08874Y7) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) ROSEMARY OIL (UNII: 8LGU7VM393) SODIUM HYDROXIDE (UNII: 55X04QC32I) TEA TREE OIL (UNII: VIF565UC2G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48951-4164-5 60 g in 1 TUBE; Type 0: Not a Combination Product 09/01/2009 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(48951-4164)
