Cold Spot Point Relief Pain Relieving Roll On - 3 Oz.

Cold Spot Point Relief Pain Relieving Roll On - 3 Oz.
SPL v2
SPL
SPL Set ID fde00a95-7bc2-4da6-8d08-d7d673313a3c
Route
TOPICAL
Published
Effective Date 2010-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (13 mL)
Inactive Ingredients
Water Arnica Cordifolia Flower Chondroitin Sulfate (bovine) Eucalyptus Globulus Leaf Glucosamine Sulfate Ilex Paraguariensis Leaf Carbomer 1342 Peppermint Oil Dimethyl Sulfone Polysorbate 20 Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-08-24

Description

Active Ingredients: Menthol


Medication Information

Warnings and Precautions

Warnings Section: For external use only, avoid contact with eyes, do not apply to open wounds or damaged skin, if symptoms persist for more than seven days discontinue use and consult physician, keep out of reach of children and if swallowed consult physician, do not bandage tightly.

Indications and Usage

Use: For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains.





 
Dosage and Administration
Apply directly to effected area. Do not use more than four times per day.

Description

Active Ingredients: Menthol

Section 50565-1

Keep out of reach of children. If swallowed consult physician

Section 51727-6

Inactive Ingredients: deionized water, arnica, chondroitin sulfate, citirc acid, euclayptus oil, glucosamine sulfate, ilex paraguariesis leaf, isopropyl alcohol, peppermint oil, dimethyl sulfone, polysorbate-20, SD alcohol 40B.

Section 51945-4
ColdSpot Point Relief Pain Relieving spray, all natural ingredients.
Section 55105-1

Use: For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains.

Section 55106-9

Active Ingredients: Menthol


Structured Label Content

Indications and Usage (34067-9)

Use: For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains.





 
Dosage and Administration (34068-7)
Apply directly to effected area. Do not use more than four times per day.

Warnings and Precautions (34071-1)

Warnings Section: For external use only, avoid contact with eyes, do not apply to open wounds or damaged skin, if symptoms persist for more than seven days discontinue use and consult physician, keep out of reach of children and if swallowed consult physician, do not bandage tightly.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed consult physician

Section 51727-6 (51727-6)

Inactive Ingredients: deionized water, arnica, chondroitin sulfate, citirc acid, euclayptus oil, glucosamine sulfate, ilex paraguariesis leaf, isopropyl alcohol, peppermint oil, dimethyl sulfone, polysorbate-20, SD alcohol 40B.

Section 51945-4 (51945-4)
ColdSpot Point Relief Pain Relieving spray, all natural ingredients.
Section 55105-1 (55105-1)

Use: For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains.

Section 55106-9 (55106-9)

Active Ingredients: Menthol


Advanced Ingredient Data


Raw Label Data

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