Storage and handling
Other information Store in a cool, dry place.
Actaflex
- Manufacturer
- Nordic Clinical Center, LLC | Genco Properties
- Effective date
- 2020-01-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:44:13
Label at a glance#
ProductActaflex
Active ingredientMENTHOL
Label structure13 sections
Label contents#
Full prescribing information#
Active Ingredient Purpose
Menthol (1.25%)…………………….Topical Analgesic
OTC - PURPOSE SECTION
Uses temporary relieves of minor aches and pains of muscles and joints associated with · simple backaches · arthritis · strains · sprains · bruises
INDICATIONS & USAGE SECTION
Uses temporary relieves of minor aches and pains of muscles and joints associated with · simple backaches · arthritis · strains · sprains · bruises
WARNINGS SECTION
Warnings For external use only • Use only as directed
OTC - DO NOT USE SECTION
Do not use · with a heating pad, may blister skin · on open wounds or damaged skin
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have redness over the affected area
OTC - WHEN USING SECTION
When using this product · Avoid contacts with eyes · Do not bandage tightly
OTC - STOP USE SECTION
Stop use and consult doctor if · skin redness or excessive skin irritation develops · condition worsens or symptoms persist for more than 7 days · symptoms clear up and occur again in a few days
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions Apply generously to the area not more than 3-4 times daily. Children under 12 years of age: consult a doctor.
STORAGE AND HANDLING SECTION
Other information Store in a cool, dry place.
INACTIVE INGREDIENT SECTION
Inactive ingredients Water, Celadrin® (Esterified Fatty Acid Complex (EFAC), Glycerin, Stearyl Alcohol, Glyceryl Stearate, Stearyl Phosphate, Polyacrylamide, Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Olive Oil, C13-14 Isoparaffin, Laureth-7, Healianthus Annuus (Sunflower) Extract, Phenoxyethanol, Caprylyl Glycol, Aloe Barbadensis Leaf Juice, Hexylene Glycol, Triethaolamine, Xanthan Gum, Tocopherol, Allantoin, Pantheno, Ethylhexyglycerin
———PACKAGE LABEL.PRINCIPAL DISPLY PANEL———
Drug Facts
Active Ingredient Purpose
Menthol (1.25%)……………………Topical Analgesic
Uses temporary relieves of minor aches and pains of muscles and joints associated with · simple backaches · arthritis · strains · sprains · bruises
Warnings For external use only · Use only as directed
Do not use · with a heating pad, may blister skin · on open wounds or damaged skin
Ask a doctor before use if you have redness over the affected area
When using this product · Avoid contacts with eyes · Do not bandage tightly
Stop use and consult doctor if · skin redness or excessive skin irritation develops · condition worsens or symptoms persist for more than 7 days · symptoms clear up and occur again in a few days
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions Apply generously to the area not more than 3-4 times daily. Children under 12 years of age: consult a doctor.
Other information Store in a cool, dry place.
Inactive ingredients Water, Celadrin® (Esterified Fatty Acid Complex (EFAC), Glycerin, Stearyl Alcohol, Glyceryl Stearate, Stearyl Phosphate, Polyacrylamide, Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Olive Oil, C13-14 Isoparaffin, Laureth-7, Healianthus Annuus (Sunflower) Extract, Phenoxyethanol, Caprylyl Glycol, Aloe Barbadensis Leaf Juice, Hexylene Glycol, Triethaolamine, Xanthan Gum, Tocopherol, Allantoin, Pantheno, Ethylhexyglycerin
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72145-001-01 | 2021-07-26 | C162847 | 48780-1 | c7ccaba7-19c5-fd44-e053-dadaa90aa01b | 89e1112e-895c-4065-9fdc-bebdad5cbba6 |
| 72145-001-02 | 2021-07-26 | C162847 | 48780-1 | c7ccaba7-19c5-fd44-e053-dadaa90aa01b | 89e1112e-895c-4065-9fdc-bebdad5cbba6 |
| 72145-001-01 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-19c5-fd44-e053-dadaa90aa01b | 89e1112e-895c-4065-9fdc-bebdad5cbba6 |
| 72145-001-02 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-19c5-fd44-e053-dadaa90aa01b | 89e1112e-895c-4065-9fdc-bebdad5cbba6 |
Products#
Every source-derived product name is available through these pages.
- Actaflex
- Topical Analgesic
- MENTHOL
- WATER
- DIACETYLTARTARIC AND FATTY ACID ESTERS OF GLYCEROL
- GLYCERIN
- STEARYL ALCOHOL
- GLYCERYL STEARATE SE
- STEARYL PHOSPHATE
- POLYACRYLAMIDE (10000 MW)
- ORYZA SATIVA WHOLE
- ROSMARINUS OFFICINALIS WHOLE
- OLIVE OIL
- C13-14 ISOPARAFFIN
- LAURETH-7
- HELIANTHUS ANNUUS WHOLE
- PHENOXYETHANOL
- CAPRYLYL GLYCOL
- ALOE
- HEXYLENE GLYCOL
- TRIETHANOLAMINE 2-CYCLOHEXYL-4,6-DINITROPHENOLATE
- XANTHAN GUM
- TOCOPHEROL
- ALLANTOIN
- PANTHENOL
- ETHYLHEXYLGLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72145-001 | 72145-001-01, 72145-001-02 |
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 |
|---|---|---|---|---|---|---|
| 3ffbdf3d-d76f-4136-a237-e969fc357b97 | 89e1112e-895c-4065-9fdc-bebdad5cbba6 | 2021-07-26 | Warnings | 89e1112e-895c-4065-9fdc-bebdad5cbba6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.