COOLING ACUTE PAIN RELIEF- aesculus hippocastanum, arnica montana, bellis perennis, bryonia, calcarea carbonica, calcarea fluori

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ), ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW), BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY), BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B), OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I), CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O), BLACK COHOSH (UNII: K73E24S6X9) (BLACK
Available from:
King Bio Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
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 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
Authorization status:
unapproved homeopathic
Authorization number:
57955-7302-3

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

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.

Equal volumes of each active ingredient in 10X, 30X, and LM1 potencies. Active ingredients 50% of

total weight.

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

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.

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:

To open: unscrew cap, remove tube seal, replace cap.

Safety sealed for your protection.

Do not use if tube seal is missing.

Store at 68-77° (20-25°C).

Inactive ingredients: Cetearyl alcohol, deionized water, glyceryl stearate, jojoba seed oil, menthol,

peppermint oil, phenoxyethanol, pomegranate fruit extract, shea butter, sodium lactate, sodium stearoyl

lacyltate, sweet almond oil, sweet birch oil.

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

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:579 55-730 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HO RSE CHESTNUT (UNII: 3C18 L6 RJAZ) (HORSE CHESTNUT - UNII:3C18 L6 RJAZ)

HORSE CHESTNUT

10 [hp_X]

in 8 5 g

ARNICA MO NTANA (UNII: O8 0 TY20 8 ZW) (ARNICA MONTANA - UNII:O8 0 TY20 8 ZW)

ARNICA MONTANA

10 [hp_X]

in 8 5 g

BELLIS PERENNIS (UNII: 2HU33I0 3UY) (BELLIS PERENNIS - UNII:2HU33I0 3UY)

BELLIS PERENNIS

10 [hp_X]

in 8 5 g

BRYO NIA ALBA RO O T (UNII: T7J0 46 YI2B) (BRYONIA ALBA ROOT -

UNII:T7J0 46 YI2B)

BRYONIA ALBA ROOT

10 [hp_X]

in 8 5 g

O YSTER SHELL CALCIUM CARBO NATE, CRUDE (UNII: 2E328 21G6 I) (OYSTER

SHELL CALCIUM CARBONATE, CRUDE - UNII:2E328 21G6 I)

OYSTER SHELL CALCIUM

CARBONATE, CRUDE

10 [hp_X]

in 8 5 g

CALCIUM FLUO RIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O)

CALCIUM FLUORIDE

10 [hp_X]

in 8 5 g

BLACK CO HO SH (UNII: K73E24S6 X9 ) (BLACK COHOSH - UNII:K73E24S6 X9 )

BLACK COHOSH

10 [hp_X]

in 8 5 g

CO BALT (UNII: 3G0 H8 C9 36 2) (COBALT - UNII:3G0 H8 C9 36 2)

COBALT

10 [hp_X]

in 8 5 g

PSEUDO GNAPHALIUM O BTUSIFO LIUM (UNII: 36 XQ8 54NWW)

(PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36 XQ8 54NWW)

PSEUDOGNAPHALIUM

OBTUSIFOLIUM

10 [hp_X]

in 8 5 g

HYPERICUM PERFO RATUM (UNII: XK4IUX8 MNB) (HYPERICUM PERFORATUM -

UNII:XK4IUX8 MNB)

HYPERICUM PERFORATUM

10 [hp_X]

in 8 5 g

King Bio Inc.

PO TASSIUM CARBO NATE (UNII: BQN1B9 B9 HA) (CARBONATE ION -

UNII:7UJQ5OPE7D)

POTASSIUM CARBONATE

10 [hp_X]

in 8 5 g

PO TASSIUM PHO SPHATE, DIBASIC (UNII: CI71S9 8 N1Z) (PHOSPHATE ION -

UNII:NK0 8 V8 K8 HR)

POTASSIUM PHOSPHATE,

DIBASIC

10 [hp_X]

in 8 5 g

MAGNESIUM PHO SPHATE, DIBASIC TRIHYDRATE (UNII: HF539 G9 L3Q)

(MAGNESIUM CATION - UNII:T6 V3LHY8 38 )

MAGNESIUM PHOSPHATE,

DIBASIC TRIHYDRATE

10 [hp_X]

in 8 5 g

O XALIC ACID DIHYDRATE (UNII: 0 K2L2IJ59 O) (OXALIC ACID - UNII:9 E7R5L6 H31)

OXALIC ACID DIHYDRATE

10 [hp_X]

in 8 5 g

PHO SPHO RUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)

PHOSPHORUS

10 [hp_X]

in 8 5 g

TO XICO DENDRO N PUBESCENS LEAF (UNII: 6 IO18 2RP7A) (TOXICODENDRON

PUBESCENS LEAF - UNII:6 IO18 2RP7A)

TOXICODENDRON

PUBESCENS LEAF

10 [hp_X]

in 8 5 g

RUTA GRAVEO LENS FLO WERING TO P (UNII: N9 4C2U58 7S) (RUTA GRAVEOLENS

FLOWERING TOP - UNII:N9 4C2U58 7S)

RUTA GRAVEOLENS

FLOWERING TOP

10 [hp_X]

in 8 5 g

ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)

ZINC

10 [hp_X]

in 8 5 g

Inactive Ingredients

Ingredient Name

Stre ng th

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

JO JO BA O IL (UNII: 724GKU717M)

MENTHO L (UNII: L7T10 EIP3A)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PO MEGRANATE (UNII: 56 6 8 7D1Z4D)

SHEA BUTTER (UNII: K49 155WL9 Y)

SO DIUM LACTATE (UNII: TU7HW0 W0 QT)

SO DIUM STEARO YL LACTYLATE (UNII: IN9 9 IT31LN)

ALMO ND O IL (UNII: 6 6 YXD4DKO9 )

METHYL SALICYLATE (UNII: LAV5U50 22Y)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:579 55-730 2-3

8 5 g in 1 TUBE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 2/19 /20 14

Labeler -

King Bio Inc. (617901350)

Registrant -

King Bio Inc. (617901350)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Medical Pro ducts Labo rato ries, Inc.

0 0 229 0 30 2

api manufacture(579 55-730 2)

Revised: 9/2014

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