FRANKIE AVALONS ZERO PAIN ROLL ON- capsaicin cream 
Frankie Avalon's Venus Ltd.

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Frankie Avalon's Zero Pain Roll-On

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.

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.

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

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

Package Labeling:

Label

FRANKIE AVALONS ZERO PAIN ROLL ON 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71480-831
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71480-831-0090 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product06/08/201708/10/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/08/201708/10/2017
Labeler - Frankie Avalon's Venus Ltd. (080673443)

Revised: 10/2023
 
Frankie Avalon's Venus Ltd.