OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Menthol 5%
Active ingredient
Menthol 5%
Water, Propylene Glycol, Carbomer Homopolymer, Glycerin,
Edetate Disodium, Hydroxyacetophenone, 1,2-Hexanediol,
Mentha Arvensis Leaf, Chrysanthemum Indicum Top,
Portulaca, Polyoxyl 40 Hydrogenated Castor Oil
For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache, arthritis, strains, bruises, sprains
For external use only
avoid contact with eyes,
mucous membranes do not bandage tightly
Stop use and ask a doctor if: condition worsens
symptoms persist for more than 7 days
symptoms 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 breastfeeding, ask a health professional before use
- Adults and children 12 years and older:
Clean the affected area with mild soap and warm water, then pat dry.
Apply a thin, even layer to the affected area not more than 3 to 4 times
daily.
- Children under 12 years: consult a doctor
Temporary relief of minor aches and pains
on wounds or damaged skin with a heating pad
if allergic to menthol or any ingredient in this product
Store at 15–30°C (59–86°F)
Protect from excessive moisture and direct sunlight
Keep the carton for full labeling
Flammable: keep away from fire or flame
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85284-010-01 | External Analgesic Cream with Menthol 5% | 50 g in 1 BOTTLE | CREAM | 50 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 85284-010 | 85284-010-01 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2025-10-02 | legacy-cache | 2026-10-21 23:52:29 |
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 |
|---|---|---|---|---|---|---|
| External Analgesic Cream with Menthol 5% | MENTHOL 5% | BLOOMWELL GARDENS LLC | 402faa27-5305-c73d-e063-6394a90a36f2 | 2026-02-18 | Warnings | 85284-010-01 85284-010 85284001001 4b1bbf88-7c2d-e616-e063-6394a90a0864 402faa27-5305-c73d-e063-6394a90a36f2 |
Adverse event summaries are temporarily unavailable. Other product information remains available.