Cold Spot Point Relief Pain Relieving Gel - 32 Oz.

Cold Spot Point Relief Pain Relieving Gel - 32 Oz.
SPL v10
SPL
SPL Set ID 77147673-dc43-43c0-83a8-d71942ecbe25
Route
TOPICAL
Published
Effective Date 2010-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (115 mL) Salicylic Acid (38 mL)
Inactive Ingredients
Water Arnica Cordifolia Flower Carbomer 1342 Ilex Paraguariensis Leaf Eucalyptus Globulus Leaf Diazolidinyl Urea Glycyrrhiza Glabra Propylparaben Peppermint Oil Dimethyl Sulfone Polysorbate 80 Alcohol

Identifiers & Packaging

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

Description

Active Ingredients: Menthol, methyl salicylate


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

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, methyl salicylate

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

pain relieving gel.

Section 55106-9

Active Ingredients: Menthol, methyl salicylate


Structured Label Content

Indications and Usage (34067-9)

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)

pain relieving gel.

Section 55106-9 (55106-9)

Active Ingredients: Menthol, methyl salicylate


Advanced Ingredient Data


Raw Label Data

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