Label: ARNICA ECHINACEA cream
- NDC Code(s): 48951-1362-5
- 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 November 22, 2024
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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ACTIVE INGREDIENT
Active Ingredients: Arnica (Arnica e flor.) 3X, Bellis (Daisy) 5X, Echinacea (Purple coneflower) 5X, Hamamelis (Witch hazel) 5X, Hypericum (St. John’s Wort) 5X, Achillea (Yarrow) 6X, Aconitum (Monkshood) 6X, Arnica (e pl.tota) 6X, Atropa belladonna (Nightshade) 6X, Calendula (Calendula ex herba) 6X, Chamomilla (Chamomile) 6X, Hepar sulfuris (Liver of lime) 9X,
Symphytum (Comfrey) 9X, Mercurius vivus (Mercury amidonitrate) 9X - 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. 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 ECHINACEA
arnica echinacea creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-1362 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ) ARNICA MONTANA FLOWER 3 [hp_X] in 1 g HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) (HAMAMELIS VIRGINIANA TOP - UNII:UDA30A2JJY) HAMAMELIS VIRGINIANA TOP 5 [hp_X] in 1 g ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 5 [hp_X] in 1 g COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 9 [hp_X] in 1 g CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 6 [hp_X] in 1 g BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS 5 [hp_X] in 1 g ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 6 [hp_X] in 1 g CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 9 [hp_X] in 1 g MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY 9 [hp_X] in 1 g ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM 6 [hp_X] in 1 g CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 6 [hp_X] in 1 g ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 6 [hp_X] in 1 g ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 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 SORBIC ACID (UNII: X045WJ989B) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) FRANKINCENSE OIL (UNII: 67ZYA5T02K) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TEA TREE OIL (UNII: VIF565UC2G) MYRRH OIL (UNII: H74221J5J4) WATER (UNII: 059QF0KO0R) LAVENDER OIL (UNII: ZBP1YXW0H8) CITRUS PARADISI SEED (UNII: 12F08874Y7) CETYL ALCOHOL (UNII: 936JST6JCN) XANTHAN GUM (UNII: TTV12P4NEE) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48951-1362-5 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(48951-1362)