Indications and uses
• temporarily relief of pain and itching associated with: • arthritis • simple backache • muscle strains • bruises • cramps • muscle sprains
Cool and Heat
- Manufacturer
- Top Care | Product Quest Mfg
- Effective date
- 2018-07-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:56:19
Label at a glance#
ProductCool and Heat
Active ingredientMENTHOL
Label structure6 sections
Dosage and administration
• 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
Label contents#
Full prescribing information#
Active ingredient Purpose
Menthol 16% Topical analgesic
Uses
• temporarily relief of pain and itching associated with:
• arthritis • simple backache • muscle strains • bruises • cramps • muscle sprains
WarningsFor external use only
Flammable
• do not use while smoking or near heat or flame
• avoid long term storage above 104oF
• do not puncture or incinerate. Contents under pressure
• do not store at temperature above 120oF
When using this product
• avoid contact with eyes and mucous membranes
• do not apply to wounds or damages skin
• do not bandage tightly
• use only as directed
Stop use and ask a doctor if
• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days
•needed for longer than 1 week
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
SPL UNCLASSIFIED SECTION
If pregnant or breast-feeding, ask a health professional before use.
Directions
• 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
Inactive ingredients
Glycerin, Propylene Glycol, SD Alcohol 40, Water
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 36800-730-04 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e6b9-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-730-04 | Cool and Heat | 113 g in 1 CAN | SPRAY | 113 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Cool and Heat
- Menthol 16%
- MENTHOL
- Glycerin
- Propylene Glycol
- Alcohol
- Water
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 36800-730 | 36800-730-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL | L7T10EIP3A | ACTIB |
| Glycerin | PDC6A3C0OX | IACT |
| Propylene Glycol | 6DC9Q167V3 | IACT |
| Alcohol | 3K9958V90M | IACT |
| Water | 059QF0KO0R | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4d60a8f7-64fb-41ed-9818-514942a94852 | 5b13d4a3-83da-4938-8bbe-ffda8498c116 | 2018-07-18 | Warnings | 4d60a8f7-64fb-41ed-9818-514942a94852 5b13d4a3-83da-4938-8bbe-ffda8498c116 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.