Point Relief Cold Spot Pain Relieving Gel

Point Relief Cold Spot Pain Relieving Gel
SPL v2
SPL
SPL Set ID 391af69f-74aa-48cf-bc96-75e5c4e0e445
Route
TOPICAL
Published
Effective Date 2019-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (120 mg)
Inactive Ingredients
Water Arnica Montana Flower Indian Frankincense Bromelains Carboxypolymethylene Diazolidinyl Urea Eucalyptus Oil Glycyrrhiza Glabra Ilex Paraguariensis Leaf Peppermint Oil Methyl Salicylate Dimethyl Sulfone Polysorbate 80 Propylparaben Propylene Glycol Trolamine

Identifiers & Packaging

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

Description

menthol - USP 12%

Purpose

external analgesic


Medication Information

Purpose

external analgesic

Description

menthol - USP 12%

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, bromelain, carbomer, diazolidinyl urea, eucalyptus globulus oil, glycyrrhiza glabra (licorice) extract, ilex paraguariensis leaf (yerba mate) extract, mentha piperita (peppermint) oil, methyl salicylate, MSM (dimethyl sulfone), polysorbate-80, propyl paraben, propylene glycol, SD-alcohol 40B, triethanolamine

Active Ingredients:

menthol - USP 12%

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, bromelain, carbomer, diazolidinyl urea, eucalyptus globulus oil, glycyrrhiza glabra (licorice) extract, ilex paraguariensis leaf (yerba mate) extract, mentha piperita (peppermint) oil, methyl salicylate, MSM (dimethyl sulfone), polysorbate-80, propyl paraben, propylene glycol, SD-alcohol 40B, triethanolamine

Active Ingredients:

menthol - USP 12%

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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