Point Relief Cold Spot Pain Relieving Gel

Point Relief Cold Spot Pain Relieving Gel
SPL v4
SPL
SPL Set ID ad5d6f04-15e6-4548-95c2-32271c186bc1
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 Completed Since 2019-04-01 Until 2019-12-12

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
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
Point Relief Cold Spot Pain Relieving Gel, 3.8l (51452 035 03)

Point Relief Cold Spot Pain Relieving Gel, 120ml (51452 035 01)

Point Relief Cold Spot Pain Relieving Gel, 475ml (51452 035 02)

Point Relief Cold Spot Pain Relieving Gel, 950ml (51452 035 05)

Point Relief Cold Spot Pain Relieving Gel, 420ml(hands Free)(51452 035 04)


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
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
Point Relief Cold Spot Pain Relieving Gel, 3.8l (51452 035 03) (Point Relief cold Spot Pain Relieving Gel, 3.8L (51452-035-03))

Point Relief Cold Spot Pain Relieving Gel, 120ml (51452 035 01) (Point Relief Cold Spot Pain Relieving Gel, 120mL (51452-035-01))

Point Relief Cold Spot Pain Relieving Gel, 475ml (51452 035 02) (Point Relief cold Spot Pain Relieving Gel, 475mL (51452-035-02))

Point Relief Cold Spot Pain Relieving Gel, 950ml (51452 035 05) (Point Relief cold Spot Pain Relieving Gel, 950mL (51452-035-05))

Point Relief Cold Spot Pain Relieving Gel, 420ml(hands Free)(51452 035 04) (Point Relief cold Spot Pain Relieving Gel, 420mL(Hands Free)(51452-035-04))


Advanced Ingredient Data


Raw Label Data

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