Indications and uses
Soothing temporary relief from minor aches and pains associated with sore muscles, strains, joint discomfort, arthritis and tendinitis.
Avedana Pain Relieving Roll On
- Manufacturer
- Unipack LLC
- Effective date
- 2022-07-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-05-31 23:50:06
Label at a glance#
ProductAvedana Pain Relieving Roll On
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure13 sections
Dosage and administration
-Adults/Children 2 years and older: Roll on the affected area up to 4 times daily. -Children under 2 years of age: Consult a physician.
Label contents#
Full prescribing information#
Active ingredients
Active ingredients Purpose
Camphor 0.4%....................................................................Counter-Irritant
Natural Menthol USP 3.5%....................................................Topical Analgesic
Purpose
Active ingredients Purpose
Camphor 0.4%....................................................................Counter-Irritant
Natural Menthol USP 3.5%....................................................Topical Analgesic
Uses
Soothing temporary relief from minor aches and pains associated with sore muscles, strains, joint discomfort, arthritis and tendinitis.
Warnings
For external use only.
Flammable
Keep away from excessive heat or open flames.
Ask a doctor before using if you
Ask a doctor before using if you: have sensitive skin, are pregnant or are breast feeding.
When using this product:
When using this product:
- Avoid contact with eyes and mucous membranes.
- Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops.
- Do not bandage or use with a heating pad or device, ointments, creams, sprays or liniments.
- Wash hands with cool water after using.
Stop use and ask a doctor if:
Stop use and ask a doctor if: condition worsens, symptoms persist more than 7 days, or clear up and reoccur.
Keep out of reach of children:
Keep out of reach of children: If ingested, seek medical help and contact poison control center immediately.
Directions
-Adults/Children 2 years and older: Roll on the affected area up to 4 times daily.
-Children under 2 years of age: Consult a physician.
Inactive Ingredients:
Inactive Ingredients: Amino Methyl Propanol, Arnica montana, Boswellia serrata Extract, Carbomer, FD&C Blue #1, Glycerin USP, Ilex paraguariensis Extract, Isopropyl Alcohol USP, Propylene Glycol USP, Methyl Paraben, Purified Water, Zeodent
Directions
-Adults/Children 2 years and older: Roll on the affected area up to 4 times daily.
-Children under 2 years of age: Consult a physician.
Product Label
Avedana ® Pain Relief Roll-On | 3 fl oz. | Bottle with Applicator.
- Easy to Use and Apply.
- Fast Relief from Pain.
- Back on Run like never before.
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43749-310-03 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1d4d-111a-e063-dadaa90a10e2 | Avedana ® Pain Relief Roll-On |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43749-310-03 | Avedana Pain Relieving Roll On | 89 mL in 1 BOTTLE, WITH APPLICATOR | GEL | 89 | 6 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CAMPHOR (SYNTHETIC) | ACTIVE INGREDIENT | 5TJD82A1ET | 1 | |
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| CAMPHOR (SYNTHETIC) | ACTIVE MOIETY | 5TJD82A1ET | 1 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 1 | |
| AMINOMETHYLPROPANOL | INACTIVE INGREDIENT | LU49E6626Q | 1 | |
| ARNICA MONTANA | INACTIVE INGREDIENT | O80TY208ZW | 1 | |
| BOSWELLIA SERRATA RESIN OIL | INACTIVE INGREDIENT | 5T1XCE6K8K | 1 | |
| CARBOMER 940 | INACTIVE INGREDIENT | 4Q93RCW27E | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| ILEX PARAGUARIENSIS LEAF | INACTIVE INGREDIENT | 1Q953B4O4F | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Avedana Pain Relieving Roll On
- Menthol
- WATER
- CARBOMER 940
- SILICON DIOXIDE
- FD&C BLUE NO. 1
- ISOPROPYL ALCOHOL
- BOSWELLIA SERRATA RESIN OIL
- ILEX PARAGUARIENSIS LEAF
- ARNICA MONTANA
- GLYCERIN
- PROPYLENE GLYCOL
- METHYLPARABEN
- AMINOMETHYLPROPANOL
- CAMPHOR (SYNTHETIC)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 43749-310 | 43749-310-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| CARBOMER 940 | 4Q93RCW27E | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| BOSWELLIA SERRATA RESIN OIL | 5T1XCE6K8K | IACT |
| ILEX PARAGUARIENSIS LEAF | 1Q953B4O4F | IACT |
| ARNICA MONTANA | O80TY208ZW | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| AMINOMETHYLPROPANOL | LU49E6626Q | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
| CAMPHOR (SYNTHETIC) | 5TJD82A1ET | ACTIB |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM, AUGMENTED / TOPICAL | 8 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE / DENTAL | NA | ||
| CARBOMER 940 | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | OINTMENT, AUGMENTED / TOPICAL | 23 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / BUCCAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM, SOLUBLE / ORAL | 0.04 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRADERMAL | 1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CREAM / TOPICAL | 0.01 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO / TOPICAL | 0.15 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM / SUBLINGUAL | 0.07 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUPPOSITORY / VAGINAL | 252 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 15 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| CARBOMER 940 | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | EMULSION / TOPICAL | 6 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / SUBLINGUAL | 0.03 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | DOUCHE / VAGINAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 3.6 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GEL / VAGINAL | 8 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / DENTAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / NASAL | 250 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYSTEM / TOPICAL | 42 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / VAGINAL | 22 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SPRAY / TOPICAL | 0.2 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / TOPICAL | 0.16 %w/w | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | GEL / TOPICAL | 75 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUPPOSITORY / VAGINAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION, CONCENTRATE / ORAL | 1 mg/1ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IONTOPHORESIS | 0.1 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg |
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 |
|---|---|---|---|---|---|---|
| e362d7b9-9e5e-d240-e053-2a95a90aca72 | 59256eea-2a78-4065-82b7-ac81283c2a3e | 2022-07-09 | Warnings | e362d7b9-9e5e-d240-e053-2a95a90aca72 59256eea-2a78-4065-82b7-ac81283c2a3e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.