Dosage and administration
Adults ands children 2 years of age and older: Spray to affected area not more than 3 to 4 times daily. Leave it on. Children under 2 years of age: Consult a physician
Topical Analgesic Spray
- Manufacturer
- I Shay Cosmetics Inc
- Effective date
- 2022-10-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:51:04
Label at a glance#
ProductHielo Mineral
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure9 sections
Storage and handling
Store at room temperature between 15 °and 30°C (59°-86°F)
Label contents#
Full prescribing information#
Active Ingredient
Menthol 2%..................... Topical Analgesic
Camphor 3%................... Topical Analgesic
OTC - PURPOSE SECTION
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. Cooling pain relief.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
WARNINGS - Keep out of reach of children
INDICATIONS & USAGE SECTION
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. Cooling pain relief.
Inactive Ingredients
Ethanol, Water, Methyl Salicylate, Hydrogenated Castor Oil, FD&C Blue No. 1.
Warnings
For external use only
Avoid contact with eyes
Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Do not apply to wounds or damaged skin
Do not bandage tightly
If pregnant or breast-feeding, ask a health professional before use
Keep out of reach of children
If swallowed, get medical help or contact a poison control center right away
DIRECTIONS
Adults ands children 2 years of age and older: Spray to affected area not more than 3 to 4 times daily. Leave it on.
Children under 2 years of age: Consult a physician
Other Information
Store at room temperature between 15 °and 30°C (59°-86°F)
label
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65112-261-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-44c9-111a-e063-dadaa90a10e2 | Topical Analgesic Spray |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65112-261-01 | Hielo Mineral | 254 g in 1 BOTTLE, PUMP | LIQUID | 254 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Hielo Mineral
- External Analgesic
- WATER
- ALCOHOL
- MENTHOL
- CAMPHOR (SYNTHETIC)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65112-261 | 65112-261-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
| CAMPHOR (SYNTHETIC) | 5TJD82A1ET | ACTIB |
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 |
|---|---|---|---|---|---|---|
| eb567a24-bc22-4e33-e053-2a95a90aa937 | b9e4fe8f-f39f-8b4d-e053-2995a90a3999 | 2022-10-18 | Warnings | eb567a24-bc22-4e33-e053-2a95a90aa937 b9e4fe8f-f39f-8b4d-e053-2995a90a3999 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.