Frankie Avalons Zero Pain Roll On

Manufacturer
Frankie Avalon's Venus Ltd.
Effective date
2017-06-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:15:46

Label at a glance#

ProductFrankie Avalons Zero Pain Roll On
Active ingredientCAPSAICIN
Label structure10 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.

Storage and handling

Store between 59 0 -86 0 F (15 0 -30 0 C)

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

OTC - DO NOT USE SECTION

to wounds or damaged skin. Do not bandage tightly.

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), Boswellia Serrata Extract, C13-14 Isoparaffin, Chamomilla Recutitta (Chamomile) Extract, Cimicifuga Racemosa (Black Cohosh) Extract, DMDM Hydantoin, Hydrastis Canadensis (Goldenseal) Root Extract, Isopropyl Alcohol, Laureth-7, Medicago Sativa (Alfalfa) Extract, Polyacrylamide, Polysorbate-20, Yucca Schidegera Extrat.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Use only as directed
  • If swallowed get medical attention or contact a poison control center immediately.

How to apply:

SPL UNCLASSIFIED SECTION

Apply to a small area of the skin first as a test for sensitivity for at least 60 minutes before applying to a larger area.  If discomfort persists after application, cotton swab area with rubbing alcohol.

STORAGE AND HANDLING SECTION

Store between 59 0-86 0F (15 0-30 0C)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71480-83171480-831-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
07236d26-76e9-cb12-e063-6294a90a13d53c857c2c-e29f-4cb5-bd62-c47446e345ee2023-10-07WarningsExact identifier
spl set id: 3c857c2c-e29f-4cb5-bd62-c47446e345ee

Reported adverse events (FAERS/openFDA)#

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