Label: SOOTHING ADVANCED ARNICA- arnica montana, arnica montana, radix cream
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-4000-3 - Packager: King Bio 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 September 29, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Drug Facts__________________________________________________________________________________________________________
HPUS active ingredients: Arnica montana, Arnica montana, radix. Equal volumes of each active ingredient in 6X, 30X, 6C, 30C, and LM1 potencies. Active ingredients 50% of total weight.
- INDICATIONS & USAGE
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WARNINGS
Warnings
- For external use only. Avoid contact with eyes and broken skin.
- Stop use and ask a doctor if •symptoms worsen or do not improve within 7 days. •skin irritation, redness or rash occurs.
- Nursing mothers should not apply to breast area.
- Keep out of reach of children.
- If swallowed, get medical help or contact a Poison Control Center immediately.
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
•Shake before using. •Apply generously to affected areas 2 to 3 times daily, or more often as needed. •Massage in thoroughly until absorbed. •For best results, apply immediately after the onset of symptoms. •Reapply after bathing and before bedtime for ongoing relief. •May be used before and after exercise.
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
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PURPOSE
Drug Facts
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HPUS active ingredients Purpose
Equal volumes of each active ingredient in 6X, 30X, 6C, and LM1 potencies.
Active ingredients 50% of total weight.
Arnica montana................................................bruises, muscle pain, stiffness
Arnica montana, radix.......................................soreness after exercise, inflammation
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SOOTHING ADVANCED ARNICA
arnica montana, arnica montana, radix creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-4000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 6 [hp_X] in 85 g ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT 6 [hp_X] in 85 g Inactive Ingredients Ingredient Name Strength ARNICA CHAMISSONIS FLOWER (UNII: 88WK5I8R3L) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) JOJOBA OIL (UNII: 724GKU717M) LEMON OIL (UNII: I9GRO824LL) PHENOXYETHANOL (UNII: HIE492ZZ3T) POMEGRANATE (UNII: 56687D1Z4D) SHEA BUTTER (UNII: K49155WL9Y) SODIUM LACTATE (UNII: TU7HW0W0QT) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) ALMOND OIL (UNII: 66YXD4DKO9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-4000-3 1 in 1 CARTON 1 85 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/18/2012 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations Medical Products Laboratories, Inc. 002290302 api manufacture(57955-4000)
