Cool n Heat

Manufacturer
NeilMed Pharmaceuticals, Inc.
Effective date
2020-04-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:36:56

Label at a glance#

ProductCool n Heat
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

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

Dosage and administration

Shake well – adults and children 12 year 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#

ACTIVE INGREDIENT PURPOSE

OTC - ACTIVE INGREDIENT SECTION

Menthol 16% Topical analgesic

Uses

GERIATRIC USE SECTION

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

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.

Directions:

INSTRUCTIONS FOR USE SECTION

Shake well – adults and children 12 year 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.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Glycerin, propylene Glycol, SD Alcohol 40 (55%), USP grade purified Water.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Shake well
adults and children 12 years of age and older spray on affected area not more than 3 to 4 times daily

children under 12 years of age consult a doctor

Indication & Usage

INDICATIONS & USAGE SECTION

temporarily relief of pain and itching associated with

arthritis simple backache muscle strains bruises cramps muscle sprains

OTC - Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away

If pregnant or breast-feeding, ask a health professional before use.

OTC Purpose Section

OTC - PURPOSE SECTION

temporarily relief of pain and itching associated with:

arthritis • simple backache • muscle strains • bruises • cramps • muscle sprains

Pacakge Lable with Priciple Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Priciple Display Panel Cool n Heat Packaging NDC 13709 236 01Priciple Display Panel Cool n Heat Packaging NDC 13709 236 01Pacakge Lable with Priciple Display Panel Cool n Heat Packaging NDC 13709-236-01

Reference: Priciple Display Panel Cool n Heat Packaging NDC 13709 236 01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13710-311-032020-02-14C16284748780-19d75b9d0-7cf6-f424-e053-dadaa90a57ce7ad1efd3-ba92-adf6-e053-2991aa0af938
13710-311-032020-01-31C16284748780-19d75b9d0-7cf6-f424-e053-dadaa90a57ce7ad1efd3-ba92-adf6-e053-2991aa0af938

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13710-31113710-311-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
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
a2c3ff03-e854-e6ce-e053-2995a90ad58d7ad1efd3-ba92-adf6-e053-2991aa0af9382020-04-08WarningsExact identifier
spl id: a2c3ff03-e854-e6ce-e053-2995a90ad58d
spl set id: 7ad1efd3-ba92-adf6-e053-2991aa0af938

Reported adverse events (FAERS/openFDA)#

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