Achy
- Manufacturer
- Kelada Creative Group LLC DBA SALVE
- Effective date
- 2016-12-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:48:46
Label at a glance#
ProductAchy
Active ingredientMENTHOL
Label structure8 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Menthol 1.5%
OTC - PURPOSE SECTION
Temporarily relieves the minor aches and pains associated with tendonitis, backache, leg cramps, sore muscles, arthritis, bruises, sprains, and swelling.
WARNINGS SECTION
Warnings
For external use only.
Do not use other than directed
When using this product
- avoid contact with eyes and mucous membranes
- do not apply tp wounds or broken skin
Stop use and ask a doctor if
- excessive skin irritation develops
- condition worsens
DOSAGE & ADMINISTRATION SECTION
Adults and children 3 years of age and older liberally massage to affected are not more than 4 times daily
Children under 3 years of age ask a doctor before using
INACTIVE INGREDIENT SECTION
Organic extra virgin olive oil, organic comfrey oil, organic arnica oil, beeswax, Indian lemongrass essenttial oil, French clary sage essential oil, Spanish rosemary essential oil, and Natural Vitamin E
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away (1-800-222-1222
INDICATIONS & USAGE SECTION
Temporarily relieves the minor aches and pains associated with tendonitis, backache, leg cramps, sore muscles, arthritis, bruises, sprains, and swelling.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71157-0017-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c7b4-f424-e053-dadaa90a57ce | Achy external analgesic |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71157-0017-1 | Achy | 90 mL in 1 CAN | CREAM | 90 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71157-0017 | ACHY (MENTHOL CREAM) CREAM [KELADA CREATIVE GROUP LLC DBA SALVE] | 1 | Legacy NDC, 1 package rows | 20170208_43b92d37-1561-003b-e054-00144ff88e88.zip |
Products#
Every source-derived product name is available through these pages.
- Achy
- menthol cream
- MENTHOL
- OLIVE OIL
- ARNICA MONTANA FLOWER
- COMFREY LEAF
- WEST INDIAN LEMONGRASS OIL
- ROSEMARY OIL
- WHITE WAX
- CLARY SAGE OIL
- .ALPHA.-TOCOPHEROL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71157-0017 | 71157-0017-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL | L7T10EIP3A | ACTIB |
| OLIVE OIL | 6UYK2W1W1E | IACT |
| ARNICA MONTANA FLOWER | OZ0E5Y15PZ | IACT |
| COMFREY LEAF | DG4F8T839X | IACT |
| WEST INDIAN LEMONGRASS OIL | 5BIA40E9ED | IACT |
| ROSEMARY OIL | 8LGU7VM393 | IACT |
| WHITE WAX | 7G1J5DA97F | IACT |
| CLARY SAGE OIL | 87L0D4U3M0 | IACT |
| .ALPHA.-TOCOPHEROL | H4N855PNZ1 | 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 |
|---|---|---|---|---|---|---|
| 43b92d37-1562-003b-e054-00144ff88e88 | 43b92d37-1561-003b-e054-00144ff88e88 | 2016-12-15 | Warnings | 43b92d37-1562-003b-e054-00144ff88e88 43b92d37-1561-003b-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.