Storage and handling
Store at room temperature.
CALYPXO CREAM 10% / 3% 4 OZ
- Manufacturer
- DirectRX
- Effective date
- 2023-07-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:28:28
Label at a glance#
ProductCALYPXO PAIN RELIEF
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure9 sections
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drugs Facts
OTC - ACTIVE INGREDIENT SECTION
Methyl Salicylate………10.00%
Menthol…………………3.00%
OTC - PURPOSE SECTION
Topical Analgesic
Topical Analgesic
INDICATIONS & USAGE SECTION
For temporary relief of minor aches and pains associated with simple backaches, arthritis, bruises, sprains and cramps.
WARNINGS SECTION
For external use only.
Avoid contact with eyes and mucous membranes.
Do not bandage tightly or cover treated areas.
Do not use with heating pad.
Do not apply to open wounds or damages skin.
A mild burning sensation may occur. If severe burning sensation occurs, discontinue use immediately.
If symptoms persist for more than seven days, discontinue use and consult physician.
Keep out of reach of children. If swallowed, consult physician.
If pregnant or breast feeding, contact physician prior to use.
STORAGE AND HANDLING SECTION
Store at room temperature.
INACTIVE INGREDIENT SECTION
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Diazolidinyl Urea, Isopropyl Myristate, Methyl Paraben, PEG-8, Propyl Paraben, Propylene Glycol, Sodium lauryl Sulfate, Triethanolamine.
DOSAGE & ADMINISTRATION SECTION
For adults apply directly to affected area. Repeat as necessary, but do not use more than 3-4 times daily.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72189-286-04 | GM - Gram | 72189-286 | af6f872b-e652-4b11-a50c-38807c56823b | 1 | 2021-12-08 |
| 76420-450-12 | GM - Gram | 76420-450 | e387b485-2d49-4f5c-bfa1-3c2fa94acbe0 | 1 | 2014-02-04 |
Products#
Every source-derived product name is available through these pages.
- CALYPXO PAIN RELIEF
- methyl salicylate, menthol cream
- ISOPROPYL MYRISTATE
- PROPYLENE GLYCOL
- WATER
- METHYLPARABEN
- PROPYLPARABEN
- TROLAMINE
- DIAZOLIDINYL UREA
- CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
- CETYL ALCOHOL
- POLYETHYLENE GLYCOL 400
- ALOE VERA LEAF
- SODIUM LAURYL SULFATE
- METHYL SALICYLATE
- SALICYLIC ACID
- MENTHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72189-286 | 72189-286-04 |
| 76420-450 |
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 |
|---|---|---|---|---|---|---|
| Calypxo Pain Relief | METHYL SALICYLATE, MENTHOL | Asclemed USA, Inc | bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6 | 2023-10-16 | Warnings | 76420-450 |
| 074b730e-ba74-c0de-e063-6294a90a964f | cf424c1c-f0b3-d903-e053-2995a90afd69 | 2023-10-09 | Warnings | cf424c1c-f0b3-d903-e053-2995a90afd69 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.