FRANKIE AVALONS ZERO PAIN ROLL ON- capsaicin cream

Frankie Avalons Zero Pain Roll On by

Drug Labeling and Warnings

Frankie Avalons Zero Pain Roll On by is a Otc medication manufactured, distributed, or labeled by Frankie Avalon's Venus Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

Active Ingredient

Capsaicin 0.025%

External Analgesic

USES:

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

WARNINGS:

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.

DIRECTIONS:

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.

SPL UNCLASSIFIED SECTION

OTHER INFORMATION:

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:

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.

For External Use Only

Keep Out of Reach of Children

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

How to apply:

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

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

Do not use if outside safety seal is broken or tampered with.

Package Labeling:

INGREDIENTS AND APPEARANCE

FRANKIE AVALONS ZERO PAIN ROLL ON 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71480-831
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
BLACK COHOSH (UNII: K73E24S6X9)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GOLDENSEAL (UNII: ZW3Z11D0JV)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LAURETH-7 (UNII: Z95S6G8201)
ALFALFA (UNII: DJO934BRBD)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71480-831-00	90 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	06/08/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/08/2017

Labeler - Frankie Avalon's Venus Ltd. (080673443)