Point Relief Cold Spot Pain Relieving Gel

Point Relief Cold Spot Pain Relieving Gel
SPL v1
SPL
SPL Set ID 96f1d592-6cec-412e-a5fd-cf3c4f68644f
Route
TOPICAL
Published
Effective Date 2024-02-06
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 Citric Acid Monohydrate Diazolidinyl Urea Eucalyptus Oil Glycerin Glycyrrhiza Glabra Ilex Paraguariensis Leaf Peppermint Oil Methylparaben Methyl Salicylate Dimethyl Sulfone Polysorbate 80 Propylparaben Propylene Glycol Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-26
Description

Menthol USP 12%

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Menthol USP 12%

Uses:

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

Warnings:
  • For external use only
  • Avoid contact with the eyes. 
  • Do not apply to open wounds or damaged skin
  • If symptoms persist for more than seven days, discontinue use and consult physician
Directions:

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

Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua(Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Citric Acid, Diazolidinyl Urea, Eucalyptus Globulus Oil, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Mentha Piperita (Peppermint) Oil, Methyl Paraben, Methyl Salicylate, Methylsulfonylmethane (MSM), Polysorbate-80, Propyl Paraben, Propylene Glycol, SD-Alcohol 40B, Triethanolamine.

Active Ingredients:

Menthol USP 12%

Package Labeling: 3.8l

Package Labeling: 475ml

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 muscles and joints, associated with simple backache, arthritis, bruises, strains, and/ or sprains.

Purpose

Topical Analgesic

Warnings:
  • For external use only
  • Avoid contact with the eyes. 
  • Do not apply to open wounds or damaged skin
  • If symptoms persist for more than seven days, discontinue use and consult physician
Directions:

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

Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua(Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Citric Acid, Diazolidinyl Urea, Eucalyptus Globulus Oil, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Mentha Piperita (Peppermint) Oil, Methyl Paraben, Methyl Salicylate, Methylsulfonylmethane (MSM), Polysorbate-80, Propyl Paraben, Propylene Glycol, SD-Alcohol 40B, Triethanolamine.

Active Ingredients:

Menthol USP 12%

Package Labeling: 3.8l (Package Labeling: 3.8L)

Package Labeling: 475ml

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:48.512185 · Updated: 2026-03-14T23:02:33.495898