Indications and uses
For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, simple back aches, strains, bruises, and sprains.
DIRT Pain Relieving Gel
- Manufacturer
- PURIVITAE, LLC
- Effective date
- 2023-11-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:59:02
Label at a glance#
ProductDIRT Pain Relieving Gel
Active ingredientMENTHOL
Label structure6 sections
Dosage and administration
Adults and children over 12 years of age: Children 12 years or younger: ask a doctor apply generously to affected areas rub into affected area until absorbed into the skin repeat as necessary, but no more than 4 times daily
Label contents#
Full prescribing information#
Active Ingredients:
Menthol 4%
Purpose
Topical Analgesic
Uses:
For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, simple back aches, strains, bruises, and sprains.
Warnings:
For external use only
Do not use
- on damaged or brokin skin.
When using this product
- Avoid contact with the eyes.
- Do not bandage tightly.
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.
Keep out of reach of 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
Directions:
Adults and children over 12 years of age:
Children 12 years or younger: ask a doctor
- apply generously to affected areas
- rub into affected area until absorbed into the skin
- repeat as necessary, but no more than 4 times daily
Inactive Ingredients:
Activated Charcoal, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Ilex Paraguariensis (Yerba Mate') Extract, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Propylene Glycol, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E), Triethanolamine.
Package Labeling:
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83067-363-00 | DIRT Pain Relieving Gel | 88 mL in 1 BOTTLE | GEL | 88 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- DIRT Pain Relieving Gel
- MENTHOL
- ALOE VERA LEAF
- WATER
- ARNICA MONTANA FLOWER
- INDIAN FRANKINCENSE
- CALENDULA OFFICINALIS FLOWER
- ETHYLHEXYLGLYCERIN
- EUCALYPTUS OIL
- GLYCERIN
- ILEX PARAGUARIENSIS LEAF
- TEA TREE OIL
- DIMETHYL SULFONE
- PHENOXYETHANOL
- POLYSORBATE 20
- PROPYLENE GLYCOL
- .ALPHA.-TOCOPHEROL ACETATE
- TROLAMINE
- ACTIVATED CHARCOAL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83067-363 | 83067-363-00 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| DIRT Pain Relieving Gel | MENTHOL | PURIVITAE, LLC | 89c80a8f-227d-4ec0-9327-683892e73b6a | 2023-11-06 | Warnings | 83067-363-00 83067-363 83067036300 09770368-70f8-2f7c-e063-6294a90a81ff 89c80a8f-227d-4ec0-9327-683892e73b6a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.