SCREAMIN HOT TOAST- capsaicin cream 
Q.A. Laboratories

Disclaimer: 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 Facts


Active Ingredient Purpose
Capsaicin 0.03%...................Topical analgesic

Uses temporarily relieves minor body aches and pains due to:  ar thritis pain, back pain, muscle aches,joint pain.

Warnings for external use only

Do not use immediately before or after bathing or using a hot tub, in conjunction with heating pad,under wrapping or bandage where perspiration is likely to occur.

Stop use and ask doctor if excessive irritation occurs, if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

When using this product avoid contact with eyes, mucous membranes, open wounds, cuts, abrasions and where skin touches skin, perspiration may increase the sensation of heat, rinse eyes with cold water if irritated.

Stop use and ask doctor if excessive irritation occurs, if condition worsens ,if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately

Directions apply to the region of specific pain or injury, reapply up to three times per daily, wash hands thoroughly in the event of contact, because activation takes about 1 hour, first time users should apply a small amount and increase gradually on reapplications depending on reaction.For use on children under the age of 12 consult a physician. Arthritis sufferers: Apply three times daily for two weeks. Wait twenty minutes before washing arthritic hands. Thereafter use as needed.

Other information
Store at room temperature

Inactive ingredients
Carbomer, Chamomilla Recutita (Matricaria)
Flower Extract, DMDM Hydantoin, Fragrance
(Par fum), Imidazolidinyl Urea, Methylparaben,
Polysorbate 20, Propyl Gallate,
Propylene Glycol, Propylparaben,
Triethanolamine, Water (Aqua)

Questions or comments:
1-800-4NO-PAIN,
toastproducts.com
MFD FOR: Toast Products
400 Sproul Street,
Pittsburgh, PA 15136
MFG IN USA

apply to the region of specific pain or injury

image of package

SCREAMIN HOT TOAST 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52099-8005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C 
CHAMOMILE 
DMDM HYDANTOIN 
IMIDUREA 
METHYLPARABEN 
POLYSORBATE 20 
PROPYL GALLATE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
TROLAMINE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52099-8005-1141 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34806/19/2012
Labeler - Q.A. Laboratories (065361149)
Registrant - Q.A. Laboratories (065361149)
Establishment
NameAddressID/FEIBusiness Operations
Q.A. Laboratories065361149manufacture(52099-8005)

Revised: 8/2012
Document Id: 2c7dc070-a6b5-4bb2-a9d4-b9b6c861e868
Set id: ec530b83-ddec-4a33-a746-7027d3c93059
Version: 4
Effective Time: 20120816
 
Q.A. Laboratories