FDA.reportPublic FDA data

Point Relief cold Spot Pain Relieving spray

Manufacturer
Fabrication Enterprises | Pure Source, LLC
Effective date
2019-04-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:28:31

Label at a glance#

ProductPoint Relief cold Spot Pain Relieving
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

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

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

menthol - USP 10%

Purpose:

OTC - PURPOSE SECTION

external analgesic

Uses:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

  • For external use only
  • Avoid contact with eyes

Do not apply

OTC - DO NOT USE SECTION

  • to open wounds or damaged skin
  • If symptoms persist for more than sevan days, discontinue use and consult physician

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, consult physician 
  • Do not bandage tightly

Directions:

DOSAGE & ADMINISTRATION SECTION

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

Other Ingredients:

INACTIVE INGREDIENT SECTION

aqua (deionized water), arnica montana flower (arnica) extract, chondroitin sulfate, citric acid, eucalyptus globulus oil, glucosamine sulfate, ilex paraguariensis leaf (yerba mate) extract, isopropyl alcohol, mentha piperita (peppermint) oil, MSM (dimethyl sulfone), polysorbate-20, SD-alcohol 40B

Point Relief cold Spot Pain Relieving spray, 120mL (51452-038-01)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label8Label8

Point Relief cold Spot Pain Relieving Spray, 475mL (51452-038-02)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label9Label9

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51452-03851452-038-01, 51452-038-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EUCALYPTUS OIL2R04ONI662IACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL ALCOHOLND2M416302IACT
PEPPERMINT OILAV092KU4JHIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
POLYSORBATE 207T1F30V5YHIACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
074ae475-41cf-b082-e063-6294a90a7cddcb593db6-10f3-4276-9f27-e0ccaa9eceb22023-10-09WarningsExact identifier
spl set id: cb593db6-10f3-4276-9f27-e0ccaa9eceb2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.