Label: ADVANCED ARNICA PLUS- arnica montana, arnica montana, radix, bellis perennis, bryonia, hypericum perforatum, lithium carbonicum, magnesia phasphorica, phytolacca decandra, rhus toxicdendron, ruta gravedens liquid
- NDC Code(s): 57955-3004-2
- 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 August 26, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Warnings
- KEEP OUT OF REACH OF CHILDREN
-
Direction
Initially, depress pump until primed.
Spray one dose directly into mouth.
Adults: 3 sprays 3 times per day.
Children ages 6-12: 2 sprays 3 times per day.
Consult a physician for use in children under 6 years of age.
Use additionally as needed, up to 6 times per day.
Reference image: AdvancedArnicaPlus1jpeg.jpg
- OTHER SAFETY INFORMATION
- Active ingredients
- Uses
-
Inactive Ingredients
Citrus Entract (ascorbic acid, citric acid, citrus aurantium amara fruit extract, citrus aurantium sinensis peel extract, citrus reticulata fruit extract,
demimeralized water, glycerin, lactic acid), Honeysuckle (Lonicera japonica), Polylysine, Purified water, Shagbark Hickory (Carya ovata) Bark
Extract, Steviol (Steviol glycosides).
Reference image: AdvancedArnicaPlus1jpeg.jpg
- PURPOSE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ADVANCED ARNICA PLUS
arnica montana, arnica montana, radix, bellis perennis, bryonia, hypericum perforatum, lithium carbonicum, magnesia phasphorica, phytolacca decandra, rhus toxicdendron, ruta gravedens liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-3004 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE 10 [hp_X] in 59 mL ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT 10 [hp_X] in 59 mL BELLIS PERENNIS WHOLE (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS WHOLE 10 [hp_X] in 59 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 10 [hp_X] in 59 mL HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE 10 [hp_X] in 59 mL LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66) LITHIUM CARBONATE 10 [hp_X] in 59 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 10 [hp_X] in 59 mL PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 10 [hp_X] in 59 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 10 [hp_X] in 59 mL RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 10 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) ORANGE PEEL (UNII: TI9T76XD44) CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID (UNII: 33X04XA5AT) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) BENZYLPENICILLOYL POLYLYSINE (UNII: 76479814OY) CARYA OVATA BARK (UNII: X765CF609L) STEVIOL (UNII: 4741LYX6RT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-3004-2 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/27/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/27/2022 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-3004) , api manufacture(57955-3004)