Label: COOLING ACUTE PAIN RELIEF- aesculus hippocastanum, arnica montana, bellis perennis, bryonia, calcarea carbonica, calcarea fluorica, cimicifuga racemosa, cobaltum metallicum, gnaphalium polycephalum, hypericum perforatum, kali carbonicum, kali phosphoricum, magnesia phosphorica, oxalicum acidum, phosphorus, rhus toxicodendron, ruta graveolens, zincum metallicum cream
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-4001-3 - 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 February 20, 2018
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Drug Facts__________________________________________________________________________________________________________
HPUS active ingredients:
Equal volumes of each active ingredient in 10X, 30X and LM1 potencies. Active ingredients 50% of total weight.
Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Cimicifuga racemosa, Cobaltum metallicum, Gnaphalium polycephalum, Hypericum perforatum, Kali carbonicum, Kali phosphoricum, Magnesia phosphorica, Oxalicum acidum, Phosphorus, Rhus toxicodendron, Ruta graveolens, Zincum metallicum.
- 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 10X, 30X and LM1 potencies.
Active ingredients 50% of total weight.
Aesculus hippocastanum..........................................................tired legs and feet
Arnica montana......................................................................sprains
Bellis perennis........................................................................sore muscles
Bryonia..................................................................................inflammation
Calcarea carbonica..................................................................back pain
Calcarea fluorica.....................................................................backache
Cimicifuga racemosa...............................................................leg aches
Cobaltum metallicum..............................................................muscle fatigue
Gnaphalium polycephalum.......................................................leg cramps
Hypericum perforatum............................................................cramps
Kali carbonicum.....................................................................stiff, swollen joints
Kali phosphoricum..................................................................backache
Magnesia phosphorica.............................................................muscle cramps
Oxalicum acidum....................................................................muscle aches
Phosphorus............................................................................weak joints
Rhus toxicodendron................................................................joint pain
Ruta graveolens.....................................................................body aches
Zincum metallicum.................................................................backache
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COOLING ACUTE PAIN RELIEF
aesculus hippocastanum, arnica montana, bellis perennis, bryonia, calcarea carbonica, calcarea fluorica, cimicifuga racemosa, cobaltum metallicum, gnaphalium polycephalum, hypericum perforatum, kali carbonicum, kali phosphoricum, magnesia phosphorica, oxalicum acidum, phosphorus, rhus toxicodendron, ruta graveolens, zincum metallicum creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-4001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH 10 [hp_X] in 85 g COBALT (UNII: 3G0H8C9362) (COBALT - UNII:3G0H8C9362) COBALT 10 [hp_X] in 85 g PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM 10 [hp_X] in 85 g HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 10 [hp_X] in 85 g POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE 10 [hp_X] in 85 g POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC 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 OXALIC ACID DIHYDRATE (UNII: 0K2L2IJ59O) (OXALIC ACID - UNII:9E7R5L6H31) OXALIC ACID DIHYDRATE 10 [hp_X] in 85 g PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 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 ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 10 [hp_X] in 85 g Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) JOJOBA OIL (UNII: 724GKU717M) MENTHOL (UNII: L7T10EIP3A) PEPPERMINT OIL (UNII: AV092KU4JH) PHENOXYETHANOL (UNII: HIE492ZZ3T) POMEGRANATE (UNII: 56687D1Z4D) SHEA BUTTER (UNII: K49155WL9Y) SODIUM LACTATE (UNII: TU7HW0W0QT) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) ALMOND OIL (UNII: 66YXD4DKO9) METHYL SALICYLATE (UNII: LAV5U5022Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-4001-3 1 in 1 CARTON 02/20/2018 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 02/20/2018 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc 617901350 api manufacture(57955-4001)