NeilMed Hot and Cold Pain Relief Spray

Manufacturer
NeilMed Pharmaceuticals Inc. | NeilMed Pharmaceuticals, Inc
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:04

Label at a glance#

ProductNeilMed Hot and Cold Pain Relief
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

Temporarily alleviates minor aches and pains of muscles and joints associated with Arthritis, Simple Backache, Strains, Bruises, or Sprains

Dosage and administration

Directions: Shake well – adults and children 12 years of age and older: spray product on affected area, not more than 3 to 4 times daily. – children under 12 years of age: consult a doctor.

Label contents#

Full prescribing information#

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Shake well – adults and children 12 years of age and older: spray product on affected area, not more than 3 to 4 times daily. – children under 12 years of age: consult a doctor.

Warnings

WARNINGS SECTION


For external use only.
Flammable: Do not use while smoking or near heat or flames. Avoid long term storage above 104°F. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
When using this product avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not bandage tightly. Use only as directed.
Stop use and ask doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days. Do not use for longer than 1 week.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
If pregnant or breast-feeding, ask a health professional before use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Propylene Glycol, SD Alcohol 40 (58%), USP grade Purified Water.

Uses

INDICATIONS & USAGE SECTION

Temporarily alleviates minor aches and pains of muscles and joints associated with Arthritis, Simple Backache, Strains, Bruises, or Sprains

Warnings: Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Drug Facts:

OTC - PURPOSE SECTION

Topical Analgesic

Drug Facts:

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Menthol 16.0%

Package Label - NeilMed Hot & Cold Pain Relief

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NeilMed Hot & Cold Pain Relief SprayNeilMed Hot & Cold Pain Relief Spray

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1430458menthol 16 % Topical SprayPSN3
1430458menthol 160 MG/ML Topical SpraySCD3
1430458menthol 16 % Topical SpraySY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-238-01NeilMed Hot and Cold Pain Relief118 g in 1 CANSPRAY1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-238NEILMED HOT AND COLD PAIN RELIEF (PAIN RELIEF SPRAY) SPRAY [NEILMED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 1 package rows20240112_b3d02111-7499-c2d4-e053-2a95a90ae1de.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13709-23813709-238-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
NeilMed Hot and Cold Pain ReliefPAIN RELIEF SPRAYNeilMed Pharmaceuticals Inc.b3d02111-7499-c2d4-e053-2a95a90ae1de2024-01-11WarningsExact identifier
ndc (package): 13709-238-01
ndc (product): 13709-238
ndc11 (package): 13709023801
spl id: 0eb0c83d-d076-1c8f-e063-6294a90a1423
spl set id: b3d02111-7499-c2d4-e053-2a95a90ae1de

Reported adverse events (FAERS/openFDA)#

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