Label: ARNICA 10% gel
- NDC Code(s): 48951-1342-5
- 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 18, 2024
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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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
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ARNICA 10%
arnica 10% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-1342 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 1 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM HYDROXIDE (UNII: 55X04QC32I) CITRUS PARADISI SEED (UNII: 12F08874Y7) BORIC ACID (UNII: R57ZHV85D4) SORBIC ACID (UNII: X045WJ989B) SODIUM ALGINATE (UNII: C269C4G2ZQ) TEA TREE OIL (UNII: VIF565UC2G) SUCROSE (UNII: C151H8M554) LAVENDER OIL (UNII: ZBP1YXW0H8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48951-1342-5 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(48951-1342)