Your browser does not support JavaScript! FRANKIE AVALONS ZERO PAIN ORIGINAL FORMULA ROLL-ON MAXIMUM STRENGTH PAIN RELIEVER (CAPSAICIN) LIQUID [PURE SOURCE INC.]
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FRANKIE AVALONS ZERO PAIN ORIGINAL FORMULA ROLL-ON MAXIMUM STRENGTH PAIN RELIEVER (capsaicin) liquid
[Pure Source Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Frankie Avalon's ZERO PAIN Original Formula Roll-On Maximum Strength PAIN RELIEVER


Active Ingredient

Capsaicin 0.025%

Purpose

External Analgesic

Uses:

Temporarily relieves minor aches and pains of muscles and joint due to

  • arthritis
  • strains
  • sprains
  • bursitis
  • sports injuries
  • bruises

Warnings:

  • For external use only
  • Use Only as Directed
  • Avoid contact with eyes or mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not bandage tightly

Stop use and ask your doctor if:

  • Condition worsens
  • Excessive irritation or blistering of the skin develops
  • Pain persists for more than 7 days
  • Symptoms clear up and occur again within a few days

Keep out of Reach of Children

If swallowed get immediate medical help or contact a Poison Control Center immediately.

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's skin sensitivity and usually decreases or disappears after continued use. Product may be removed from the test area by wiping with rubbing alcohol. Before use read other important information inside box.

OTHER INGREDIENTS:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Boswella 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 Extract.

Questions or comments

call 877-581-1502 or visit www.americanretailalliance.com

Frankie Avalon's ZERO PAIN Original Formula Roll-On Maximum Strength PAIN RELIEVER

"Hello everyone Frankie Avalon here and if you have suffered with pain like I have you are going to love my original formula that has sold millions of units and is still helping countless individuals with chronic arthritis pain. I'm not a pain expert but I am an expert in dealing with pain Try Zero Pain and see what it can do for you!"

8  10074  51594  4

Frankie Avalon Zero Pain is a registered trademark of Frankie Avalon's Venus, LTD
Exclusively distributed by:
American Retails Alliance Corp.
Belleair Bluffs, FL 33770

Topical Analgesic

Doctor Recommended Formula

Easy to apply
Roll-On Applicator

For the temporary relief of muscle aches and pains associated with

Arthritis Bursitis Simple Back Ache Sports Injury Bruises

Non-Greasy/Non-Staining Odorless

Directions:

Adults and children 10 years of age and older:  Apply to affected area not more than 3 to 4 times daily.  Children under 10 years of age:  consult a doctor.

Frankie Avalon's ZERO PAIN Original Formula Roll-On Maximum Strength PAIN RELIEVER
Net Wt. 3 fl oz (90ml)

Frankie Avalon's ZERO PAIN Original Formula Roll-On Maximum Strength PAIN RELIEVER 3oz/90ml (65121-496-04)

LabelOuter Label

FRANKIE AVALONS ZERO PAIN ORIGINAL FORMULA ROLL-ON MAXIMUM STRENGTH PAIN RELIEVER 
capsaicin liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65121-496
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
WATER 
INDIAN FRANKINCENSE 
C13-14 ISOPARAFFIN 
DMDM HYDANTOIN 
GOLDENSEAL 
ISOPROPYL ALCOHOL 
LAURETH-7 
ALFALFA 
POLYSORBATE 20 
YUCCA SCHIDIGERA 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65121-496-041 in 1 BOX
190 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/10/2013
Labeler - Pure Source Inc. (969241041)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source Inc.969241041manufacture(65121-496)

Revised: 7/2013
 
Pure Source Inc.

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