Dosage and administration
Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. Children under two-years of age: consult a physician
SMOOTH GATOR Head-Ezz Topical Analgesic Cream
- Manufacturer
- Smooth Gator LLC | Pure Source, LLC
- Effective date
- 2024-06-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:13:31
Label at a glance#
ProductSMOOTH GATOR Head-Ezz Analgesic
Active ingredientMENTHOL
Label structure7 sections
Label contents#
Full prescribing information#
Active Ingredients:
Menthol 3.00%
Purpose
Topical Analgesic
Indications:
For the temporary relief of minor aches and pains.
Warnings
- For external use only.
- Avoid contact with eyes.
- If symptoms persist for more than seven days, discontinue use and consult physician.
Keep out of reach of children.
- If swallowed, consult physician.
- Do not apply to wounds or damaged skin.
- Do not bandage tightly.
Directions:
- Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
- Children under two-years of age: consult a physician
Additional Information:
Store at room temperature
Inactive Ingredients:
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camphor, Diazolidinyl Urea, Eucalyptus Globulus Oil, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Methyl Paraben, Methyl Salicylate, Mineral Oil, Parfum (Fragrance), PEG-100 Stearate, Polysorbate-20, Propyl Paraben, Propylene Glycol, Retinyl Palmitate (Vitamin E), Rosmarinus Officinalis (Rosemary) Extract, Tocopheryl Acetate (Vitamine E), Triethanolamine.
Package Labelling:
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70673-501-00 | SMOOTH GATOR Head-Ezz Analgesic | 60 mL in 1 BOTTLE | CREAM | 60 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- SMOOTH GATOR Head-Ezz Analgesic
- MENTHOL
- ALOE VERA LEAF
- WATER
- DIAZOLIDINYL UREA
- EUCALYPTUS OIL
- GLYCERIN
- GLYCERYL MONOSTEARATE
- LICORICE
- MELALEUCA ALTERNIFOLIA LEAF
- PEPPERMINT OIL
- METHYLPARABEN
- METHYL SALICYLATE
- MINERAL OIL
- PEG-100 STEARATE
- POLYSORBATE 20
- PROPYLPARABEN
- PROPYLENE GLYCOL
- .ALPHA.-TOCOPHEROL
- ROSEMARY
- TROLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70673-501 | 70673-501-00 |
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 |
|---|---|---|---|---|---|---|
| SMOOTH GATOR Head-Ezz Analgesic | MENTHOL | Smooth Gator LLC | 02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd | 2024-06-10 | Warnings | 70673-501-00 70673-501 70673050100 1a820f59-518c-a238-e063-6294a90a1d1f 02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.