Cooling Acute Pain Relief

Cooling Acute Pain Relief
SPL v2
SPL
SPL Set ID 4aa6e885-b0a5-48be-b093-ee4cdc88619c
Route
TOPICAL
Published
Effective Date 2018-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Horse Chestnut (10 [hp_X]) Arnica Montana Bellis Perennis Bryonia Alba Root Oyster Shell Calcium Carbonate, Crude Fluoride Ion Black Cohosh Cobalt Pseudognaphalium Obtusifolium Hypericum Perforatum Carbonate Ion Phosphate Ion Magnesium Cation Oxalic Acid Phosphorus Toxicodendron Pubescens Leaf Ruta Graveolens Flowering Top Zinc
Inactive Ingredients
Cetostearyl Alcohol Water Glyceryl Monostearate Jojoba Oil Menthol Peppermint Oil Phenoxyethanol Pomegranate Shea Butter Sodium Lactate Sodium Stearoyl Lactylate Almond Oil Methyl Salicylate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-02-20

Description

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.


Medication Information

Warnings and Precautions

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 bre ast area.
  • Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center immediately.
Indications and Usage

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

Dosage and 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.

Description

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.

Section 50565-1
  • Keep out of reach of children.
Section 51727-6

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.

Section 51945-4

Section 55105-1

 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

Section 55106-9

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.

Section 60561-8

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).

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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 bre ast area.
  • Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center immediately.
Section 50565-1 (50565-1)
  • Keep out of reach of children.
Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

 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

Section 55106-9 (55106-9)

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.

Section 60561-8 (60561-8)

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).

Advanced Ingredient Data


Raw Label Data

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