Label: ARNICA HYPERICUM DKS ointment
- NDC Code(s): 48951-1350-5
- 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 August 4, 2021
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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ACTIVE INGREDIENT
Active Ingredient: Hypericum (St. John’s Wort) 5X/10X, Aconitum (Monkshood) 6X, Aurum met. (Metallic gold) 6X, Oxalis (Wood sorrel) 6X, Stibium met. (Antimony) 6X, Urtica dioica (Stinging nettle) 6X, Arnica 6X/12X, Granite (Primitive rock containing quartz, feldspar, mica) 12X, Rosa (Garden rose) 6X/15X
- 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. Consult a doctor before use for serious conditions, if conditions worsen or persist, or accidental ingestion occurs. Contains traces of lactose. 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
ARNICA HYPERICUM DKS
arnica hypericum dks ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-1350 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength URTICA DIOICA (UNII: 710FLW4U46) (URTICA DIOICA - UNII:710FLW4U46) URTICA DIOICA 6 [hp_X] in 1 g SEDUM ROSEUM WHOLE (UNII: RH0WP583U3) (SEDUM ROSEUM WHOLE - UNII:RH0WP583U3) SEDUM ROSEUM WHOLE 6 [hp_X] in 1 g ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ) ARNICA MONTANA FLOWER 6 [hp_X] in 1 g GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD 6 [hp_X] in 1 g PENOXSULAM (UNII: 784ELC1SCZ) (PENOXSULAM - UNII:784ELC1SCZ) PENOXSULAM 12 [hp_X] in 1 g ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 6 [hp_X] in 1 g OXALIS STRICTA WHOLE (UNII: 3STW243384) (OXALIS STRICTA WHOLE - UNII:3STW243384) OXALIS STRICTA WHOLE 6 [hp_X] in 1 g ANTIMONY (UNII: 9IT35J3UV3) (ANTIMONY - UNII:9IT35J3UV3) ANTIMONY 6 [hp_X] in 1 g ST. JOHN'S WORT (UNII: UFH8805FKA) (ST. JOHN'S WORT - UNII:UFH8805FKA) ST. JOHN'S WORT 5 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength CITRUS PARADISI SEED (UNII: 12F08874Y7) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) OLIVE OIL (UNII: 6UYK2W1W1E) LANOLIN (UNII: 7EV65EAW6H) YELLOW WAX (UNII: 2ZA36H0S2V) WATER (UNII: 059QF0KO0R) TEA TREE OIL (UNII: VIF565UC2G) SUNFLOWER OIL (UNII: 3W1JG795YI) SORBIC ACID (UNII: X045WJ989B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48951-1350-5 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 Arnica Hypericum DKS 043471163 manufacture(48951-1350)
