OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Menthol 10.5%
SUNMED Topical Spray with MENTHOL
- Manufacturer
- Sunflora Inc. | Inspec Solutions LLC.
- Effective date
- 2022-03-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:04:44
Label at a glance#
ProductSUNMED Topical with Menthol
Active ingredientMENTHOL
Label structure10 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Menthol 10.4% ................. Topical Analgesic
INDICATIONS & USAGE SECTION
Uses Temporary relief from minor aches and pains of muscles and joints associated with, arthritis, simple backache, strains, bruises, sprains.
WARNINGS SECTION
For external use only
OTC - WHEN USING SECTION
When using this product, avoid contact with eyes and mucous membranes., do not apply to wound or damage skin, do not bandage, do not use with heating pad or device.
OTC - STOP USE SECTION
Stop use and ask a doctor if, condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Adults and children 2 years of age and older: Apply to affected area no more than 3 to 4 times daily. Wash hands with soap. Children under 2 years of age: consult a doctor.
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS
Aloe Barbadensis Leaf Extract
Arctium Lappa Root (Burdock) Extract
Arnica Montana Flower Extract
Boswellia Carterii Resin Extract
Calendula Officinalis Extract
Camellia Sinensis Leaf Extract
Camphor
Carbomer
FD&C Blue #1
FD&C Yellow #5
Full Spectrum Industrial Hemp Extract
Glycerin
Ilex Paraguariensis (Mate) Leaf Extract
Isopropyl Alcohol
Isopropyl Myristate
Melissa Officinalis (Lemon Balm) Leaf Extract
Silica
Tocopheryl Acetate
Triethanolamine
Water
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73240-903-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4f5a-111a-e063-dadaa90a10e2 | SUNMED Topical Spray with MENTHOL |
Products#
Every source-derived product name is available through these pages.
- SUNMED Topical with Menthol
- Menthol
- ECHINACEA ANGUSTIFOLIA LEAF
- HEMP
- DEHYDRATED ALCOHOL
- GREEN TEA LEAF
- WATER
- ARNICA MONTANA FLOWER
- ISOPROPYL MYRISTATE
- ILEX PARAGUARIENSIS LEAF
- CALENDULA OFFICINALIS FLOWER
- CHAMOMILE
- DIMETHYL SULFONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 73240-903 | 73240-903-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ECHINACEA ANGUSTIFOLIA LEAF | FS7G8S6PJ8 | IACT |
| HEMP | TD1MUT01Q7 | IACT |
| DEHYDRATED ALCOHOL | 3K9958V90M | IACT |
| GREEN TEA LEAF | W2ZU1RY8B0 | IACT |
| WATER | 059QF0KO0R | IACT |
| ARNICA MONTANA FLOWER | OZ0E5Y15PZ | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| ILEX PARAGUARIENSIS LEAF | 1Q953B4O4F | IACT |
| CALENDULA OFFICINALIS FLOWER | P0M7O4Y7YD | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
| CHAMOMILE | FGL3685T2X | IACT |
| DIMETHYL SULFONE | 9H4PO4Z4FT | 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 |
|---|---|---|---|---|---|---|
| db6f83c3-c17e-b253-e053-2995a90a5cc2 | db6f7da5-aed6-cb18-e053-2995a90abbfc | 2022-03-30 | Warnings | db6f83c3-c17e-b253-e053-2995a90a5cc2 db6f7da5-aed6-cb18-e053-2995a90abbfc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.