Point Relief Cold Spot Pain Relieving Roll-on

Point Relief Cold Spot Pain Relieving Roll-on
SPL v2
SPL
SPL Set ID 3f1db0ad-aaa8-4e14-9349-45057e0fb4a6
Route
TOPICAL
Published
Effective Date 2019-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (140 mg)
Inactive Ingredients
Water Arnica Montana Flower Indian Frankincense Carboxypolymethylene Eucalyptus Oil Glucosamine Sulfate Glycyrrhiza Glabra Ilex Paraguariensis Leaf Peppermint Oil Methylisothiazolinone Dimethyl Sulfone Polysorbate 20 Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-01

Description

menthol - USP 14%

Purpose

external analgesic


Medication Information

Purpose

external analgesic

Description

menthol - USP 14%

Uses:

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

Purpose:

external analgesic

Warnings:
  • For external use only
  • Avoid contact with eyes
Directions:

Apply directly to affected area. Do not use more than four fimes per day.

Do Not Apply
  • to open wounds or damaged skin
  • If symptoms persist for more than sevan days, discontinue use and consult physician
Package Labeling:

Other Ingredients:

aqua (deionized water), arnica montana flower (arnica) extract, boswellia serrata extract, carbomer, chondroitin sulfate, eucalyptus globulus oil, glucosamine sulfate, glycrrhiza glabra (licorice) extract, ilex paraguariensis leaf (yerba mate) extract, mentha piperita (peppermint) oil, methylisothiazolinone, MSM (dimethyl sulfone), polysorbate-20, SD-alcohol 40B, triethanolamine

Active Ingredients:

menthol - USP 14%

Keep Out of Reach of Children
  • If swallowed, consult physician 
  • Do not bandage tightly

Structured Label Content

Uses:

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

Purpose:

external analgesic

Warnings:
  • For external use only
  • Avoid contact with eyes
Directions:

Apply directly to affected area. Do not use more than four fimes per day.

Do Not Apply (Do not apply)
  • to open wounds or damaged skin
  • If symptoms persist for more than sevan days, discontinue use and consult physician
Package Labeling:

Other Ingredients:

aqua (deionized water), arnica montana flower (arnica) extract, boswellia serrata extract, carbomer, chondroitin sulfate, eucalyptus globulus oil, glucosamine sulfate, glycrrhiza glabra (licorice) extract, ilex paraguariensis leaf (yerba mate) extract, mentha piperita (peppermint) oil, methylisothiazolinone, MSM (dimethyl sulfone), polysorbate-20, SD-alcohol 40B, triethanolamine

Active Ingredients:

menthol - USP 14%

Keep Out of Reach of Children (Keep out of reach of children)
  • If swallowed, consult physician 
  • Do not bandage tightly

Advanced Ingredient Data


Raw Label Data

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