Indications and uses
Temporary relief of minor aches and pains of muscles and joints.
61010-8201. Pain Relief Spray
- Manufacturer
- Safetec of America, Inc. | Safetec of America, Inc
- Effective date
- 2024-02-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:08:33
Label at a glance#
ProductAnalgesic
Active ingredientMENTHOL
Label structure8 sections
Dosage and administration
For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.
Label contents#
Full prescribing information#
Active Ingredients
USP Menthol 7%
Purpose
Topical Analgesic
Uses
Temporary relief of minor aches and pains of muscles and joints.
Warnings
For external use only.
Flammable.
Keep away from flame.
Keep out of reach of children.
If swallowed get medical help or contact a poison control center right away. Avoid contact with eyes.
OTC - DO NOT USE SECTION
Do not apply to open wounds or damaged skin. Do not bandage tightly.
OTC - ASK DOCTOR SECTION
Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates,including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.
Directions
For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.
Other Information
Store at room temperature.
Inactive Ingredients
Water, Isopropyl Alcohol, Glycerol, Eucalyptus Leaf Oil, Wintergreen Leaf Oil, Peppermint Oil, Coconut Oil.
Principal Display Panel - Pain Relief Spray Bottle Label
NDC 61010-XXXX-X
Safetec
PAIN
RELIEF
SPRAY
MEDICATED FAST-ACTING
For temporary relief of minor aches and pains
2 fl. oz. (59.1 ml)
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61010-8201-0 | Analgesic | 0.059 L in 1 BOTTLE, SPRAY | SPRAY | 0.059 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61010-8201 | ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240214_79e3b0e7-4ba5-4b9d-a980-5b6f18dba802.zip |
Products#
Every source-derived product name is available through these pages.
- Analgesic
- menthol
- WATER
- ISOPROPYL ALCOHOL
- GLYCERIN
- EUCALYPTUS OIL
- METHYL SALICYLATE
- PEPPERMINT OIL
- COCONUT OIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61010-8201 | 61010-8201-0 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| EUCALYPTUS OIL | 2R04ONI662 | IACT |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| COCONUT OIL | Q9L0O73W7L | IACT |
| MENTHOL | L7T10EIP3A | 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 |
|---|---|---|---|---|---|---|
| Analgesic | MENTHOL | Safetec of America, Inc. | 79e3b0e7-4ba5-4b9d-a980-5b6f18dba802 | 2024-02-04 | Warnings | 61010-8201-0 61010-8201 61010820100 10981167-c8a2-e068-e063-6394a90ab165 79e3b0e7-4ba5-4b9d-a980-5b6f18dba802 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.