Frankie Avalons ZERO PAIN Roll-On Pain Reliever

Manufacturer
WHY ENTERPRISES LLC
Effective date
2024-06-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:47

Label at a glance#

ProductFrankie Avalons ZERO PAIN Roll-On Pain Reliever
Active ingredientCAPSAICIN
Label structure7 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.025%

OTC - PURPOSE SECTION

External Analgesic

USES:

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

WARNINGS:

WARNINGS SECTION

For external use only. Avoid contact with the eyes. If condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Do not apply to wounds or damaged skin. Do not bandage tightly.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

OTHER INFORMATION:

SPL UNCLASSIFIED SECTION

Products containing capsaicin may cause a burning, stinging or tingling sensation where applied. This is a natural reaction and varies with each individual and usually decreases or disappears after continued use. Read all information on the box and the opposite panel before use.

OTHER INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana (Arnica) Extract, Boswella Serrata Extract, C13-14 Isoparaffin, Chamomilla Recutitta (Chamomile) Extract, Cimicifuga Racemosa (Black Cohosh) Extract, DMDM Hydantoin, Glycerin, Hydrastis Canadensis (Goldenseal) Root Extract, Isopropyl Alcohol, Laureth-7, Medicago Sativa (Alfalfa) Extract, Polyacrylamide, Polysorbate-20, Yucca Schidegera Extract. 

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252006capsaicin 0.025 % Topical SolutionPSN1
252006capsaicin 0.25 MG/ML Topical SolutionSCD1
252006capsaicin 0.025 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84413-481-00Frankie Avalons ZERO PAIN Roll-On Pain Reliever90 mL in 1 BOTTLE, WITH APPLICATORLIQUID901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84413-481FRANKIE AVALONS ZERO PAIN ROLL-ON PAIN RELIEVER (CAPSAICIN) LIQUID [WHY ENTERPRISES LLC]1Current NDC, 1 package rows20240618_e32acb5f-5bc3-4228-b037-6315d080f556.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84413-48184413-481-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Frankie Avalons ZERO PAIN Roll-On Pain RelieverCAPSAICINWHY ENTERPRISES LLCe32acb5f-5bc3-4228-b037-6315d080f5562024-06-17WarningsExact identifier
ndc (package): 84413-481-00
ndc (product): 84413-481
ndc11 (package): 84413048100
spl id: 1b120e3c-58de-2ef6-e063-6294a90ae2d6
spl set id: e32acb5f-5bc3-4228-b037-6315d080f556

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.