Label: RHEUMA ointment
- NDC Code(s): 48951-8350-5
- 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 11, 2024
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Organic olive oil, Lanolin, Beeswax, Sunflower seed oil, Camphor, Birch leaf extract, Chamomile flower extract, Rosemary herb extract, Fir needle oil, Pine needle oil, Rosemary oil, Spring water, Lemon oil, Menthol, Peppermint oil, Lavender oil, Tea tree oil, Purified turpentine oil, Grapefruit seed extract, Sage oil, Capsicum oleoresin, Red copper oxide
- 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
RHEUMA
rheuma ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-8350 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 COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 1 [hp_X] in 1 g ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 1 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength LAVENDER OIL (UNII: ZBP1YXW0H8) TURPENTINE OIL (UNII: C5H0QJ6V7F) TEA TREE OIL (UNII: VIF565UC2G) SAGE OIL (UNII: U27K0H1H2O) CAPSICUM OLEORESIN (UNII: UW86K581WY) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) ROSEMARY OIL (UNII: 8LGU7VM393) CITRUS PARADISI SEED (UNII: 12F08874Y7) CUPROUS OXIDE (UNII: T8BEA5064F) YELLOW WAX (UNII: 2ZA36H0S2V) PEPPERMINT OIL (UNII: AV092KU4JH) MENTHOL (UNII: L7T10EIP3A) LEMON OIL (UNII: I9GRO824LL) CAMPHOR (NATURAL) (UNII: N20HL7Q941) BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO) CHAMOMILE (UNII: FGL3685T2X) ROSEMARY (UNII: IJ67X351P9) WATER (UNII: 059QF0KO0R) OLIVE OIL (UNII: 6UYK2W1W1E) SUNFLOWER SEED (UNII: R9N3379M4Z) ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ) LANOLIN (UNII: 7EV65EAW6H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48951-8350-5 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(48951-8350)