Label: ANANASSA ARNICA cream
- NDC Code(s): 48951-1310-5
- 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 January 22, 2024
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
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WARNINGS
Warning: 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. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANANASSA ARNICA
ananassa arnica creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-1310 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LARIX DECIDUA RESIN (UNII: AD8LJ73GQF) (LARIX DECIDUA RESIN - UNII:AD8LJ73GQF) LARIX DECIDUA RESIN 2 [hp_X] in 1 g PINEAPPLE (UNII: 2A88ZO081O) (PINEAPPLE - UNII:2A88ZO081O) PINEAPPLE 2 [hp_X] in 1 g ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ) ARNICA MONTANA FLOWER 3 [hp_X] in 1 g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 6 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength ROSEMARY OIL (UNII: 8LGU7VM393) XANTHAN GUM (UNII: TTV12P4NEE) MYRRH OIL (UNII: H74221J5J4) STEARIC ACID (UNII: 4ELV7Z65AP) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) SORBIC ACID (UNII: X045WJ989B) FRANKINCENSE OIL (UNII: 67ZYA5T02K) CITRUS PARADISI SEED (UNII: 12F08874Y7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48951-1310-5 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(48951-1310)