Label: WARMING ARTHRITIC PAIN AND JOINT RELIEF- actaea spicata, aescuculus hippocastanum, arnica montana, bellis perennis, bryonia, calcarea carbonica, calcarea fluorica, causticum, cimicifuga racemosa, formicum acidum, hypericum perforatum, lithium carbonicum, magnesia phosphorica, phosphorus, phytolacca decandra, pulsatilla, rhododendron chrysanthum, rhus tox, ruta graveolens, salicylicum acidum, sepia, zincum metallicum cream
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-0935-3 - Packager: King Bio Inc.
- Category: HUMAN PRESCRIPTION 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 December 17, 2018
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Active Ingredients
Actaea spicata, Aescuculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Causticum, Cimicifuga racemosa, Formicum acidum, Hypericum perforatum, Lithium carbonicum, Magnesia phosphorica, Phosphorus, Phytolacca decandra, Pulsatilla, Rhododendron chrysanthum, Rhus tox, Ruta graveolens, Salicylicum acidum, Sepia, Zincum metallicum
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Purpose
Actaea spicata...............................fatigued joints
Aescuculus hippocastanum..............aching limbs
Arnica montana..............................body aches
Bellis perennis................................muscular soreness
Bryonia.........................................physical weakness
Calcarea carbonica.........................leg cramps
Calcarea fluorica............................backache
Causticum....................................arthritic symptoms
Cimicifuga racemosa......................restless limbs, soreness
Formicum acidum..........................stiff joints
Hypericum perfoatum.....................joint discomfort
Lithium carbonicum.......................aching joints, stiffness
Magnesia phosphorica...................leg cramps
Phosphorus..................................elbow and shoulder joint discomfort
Phytolacca decandra......................rheumatic pains
Pulsatilla......................................hip and joint discomfort
Rhododendron chrysanthum...........achy shoulders
Rhus tox......................................sore tendons and ligaments
Ruta graveolens...........................lower back discomfort
Salicylicum acidum.......................knee discomforts
Sepia..........................................stiffness, restless limbs
Zincum metallicum.......................backache
- Uses
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Warnings
For external use only. When using this product- use ony as directed. do not bandage tightly or use witha heating pad. avoid contact with eyes or mucous membranes. do not apply to wounds or damages skin. avoid sun exposure to area applied. Stop use and ask a doctor if- condition worsens. smptoms persist for more than 7 dayd or clear up and occur again within a few days. severe skin irritation occurs or allergic reaction develops. If pregnant or breast-feeding, ask a healthcare professional before use. Nursing mothers should not apply to breast area. Keep out of reac of children. If swallowed, b get medical help or contact a Poison Control Center immediately.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Information
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Inactive Ingredients
Water, Aloe barbadensis leaf juice, Simmondsia chinensis (jojoba) seed oil, glycerin, caprylic/capric triglyceride, Carya ovata bark extract, cetearyl alcohol, potassium cetyl phosphate, arginine HCL, dimethyl sulfone, ceteayl olivate, sorbitan olivate algin, xanthan gum, caprylhydroxamic acid, caprylyl glycol, Capsicum annuum resin, Cinnamomum cassia leaf oil, Citrus reticulata fruit extract, Betula lenta (birch) oil, Eugenia cayopyllus (clove) flower oil, camphor, Citrus aurantium amara fruit extract, Citrus aurantium sinensis peel extract, potassium chloride, sodium chloride, citric acid, ascorbic acid, lactic acid, vanillin, sodium hydroxide.
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INGREDIENTS AND APPEARANCE
WARMING ARTHRITIC PAIN AND JOINT RELIEF
actaea spicata, aescuculus hippocastanum, arnica montana, bellis perennis, bryonia, calcarea carbonica, calcarea fluorica, causticum, cimicifuga racemosa, formicum acidum, hypericum perforatum, lithium carbonicum, magnesia phosphorica, phosphorus, phytolacca decandra, pulsatilla, rhododendron chrysanthum, rhus tox, ruta graveolens, salicylicum acidum, sepia, zincum metallicum creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57955-0935 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0) ACTAEA SPICATA ROOT 10 [hp_X] in 85 g HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT 10 [hp_X] in 85 g ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 10 [hp_X] in 85 g BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS 10 [hp_X] in 85 g BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 10 [hp_X] in 85 g OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X] in 85 g CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 10 [hp_X] in 85 g CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 10 [hp_X] in 85 g BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH 10 [hp_X] in 85 g FORMIC ACID (UNII: 0YIW783RG1) (FORMIC ACID - UNII:0YIW783RG1) FORMIC ACID 10 [hp_X] in 85 g HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 10 [hp_X] in 85 g RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG 10 [hp_X] in 85 g LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66) LITHIUM CARBONATE 10 [hp_X] in 85 g MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 10 [hp_X] in 85 g PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 10 [hp_X] in 85 g PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 10 [hp_X] in 85 g ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 10 [hp_X] in 85 g RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U) RHODODENDRON AUREUM LEAF 10 [hp_X] in 85 g TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 10 [hp_X] in 85 g RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 10 [hp_X] in 85 g SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 10 [hp_X] in 85 g SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 10 [hp_X] in 85 g ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 10 [hp_X] in 85 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) JOJOBA OIL (UNII: 724GKU717M) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL TRICAPRYLATE (UNII: 6P92858988) CARYA OVATA BARK (UNII: X765CF609L) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) SODIUM ALGINATE (UNII: C269C4G2ZQ) XANTHAN GUM (UNII: TTV12P4NEE) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPSICUM (UNII: 00UK7646FG) CHINESE CINNAMON LEAF OIL (UNII: 4U4V2F2E4Y) TANGERINE JUICE (UNII: 391Y6QJ4XR) METHYL SALICYLATE (UNII: LAV5U5022Y) CLOVE OIL (UNII: 578389D6D0) CAMPHOR LEAF OIL (UNII: 51D0RGY52V) CITRUS AURANTIUM FRUIT RIND (UNII: 055456JHI7) BITTER ORANGE OIL (UNII: 9TLV70SV6I) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SODIUM CHLORIDE (UNII: 451W47IQ8X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ASCORBIC ACID (UNII: PQ6CK8PD0R) LACTIC ACID (UNII: 33X04XA5AT) VANILLIN (UNII: CHI530446X) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-0935-3 1 in 1 CARTON 01/01/2018 1 85 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2018 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-0935)