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 
King Bio Inc.

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.

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Cooling Acute Pain Relief

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.

Uses: for temporary relief of symptoms: •back and neck pain •muscle and joint pain •muscle cramps and stiffness •inflamed muscles and joints •muscle tension and soreness •body aches •tired legs and feet •stiff and swollen joints

Warnings:

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 information:

Inactive ingredients: Cetearyl alcohol, deionized water, glyceryl stearate, jojoba seed oil, menthol, peppermint oil, phenoxyethanol, pomegranate fruit extract, shea butter, sodium lactate, sodium stearoyl lactylate, sweet almond oil, sweet birch oil.

 Drug Facts

__________________________________________________________________________________________________________________

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

image description

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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-4001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT10 [hp_X]  in 85 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA10 [hp_X]  in 85 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS10 [hp_X]  in 85 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT10 [hp_X]  in 85 g
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]  in 85 g
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE10 [hp_X]  in 85 g
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH10 [hp_X]  in 85 g
COBALT (UNII: 3G0H8C9362) (COBALT - UNII:3G0H8C9362) COBALT10 [hp_X]  in 85 g
PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM10 [hp_X]  in 85 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM10 [hp_X]  in 85 g
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE10 [hp_X]  in 85 g
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC10 [hp_X]  in 85 g
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE10 [hp_X]  in 85 g
OXALIC ACID DIHYDRATE (UNII: 0K2L2IJ59O) (OXALIC ACID - UNII:9E7R5L6H31) OXALIC ACID DIHYDRATE10 [hp_X]  in 85 g
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]  in 85 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF10 [hp_X]  in 85 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP10 [hp_X]  in 85 g
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC10 [hp_X]  in 85 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57955-4001-31 in 1 CARTON02/20/2018
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/20/2018
Labeler - King Bio Inc. (617901350)
Registrant - King Bio Inc. (617901350)
Establishment
NameAddressID/FEIBusiness Operations
King Bio Inc617901350api manufacture(57955-4001)

Revised: 2/2018
Document Id: 9504765e-1950-4fcd-b2ce-fda97ea7f9d4
Set id: 4aa6e885-b0a5-48be-b093-ee4cdc88619c
Version: 2
Effective Time: 20180220
 
King Bio Inc.