SCREAMIN MENTHOL TOAST  - menthol 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
Menthol 4%..........................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 a suitable amount of product to the region of specific pain or injury, avoiding sensitive areas reapply up to three times per daily, wash hands thoroughly in the event of contact. 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 suf ferers: 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
Boswellia Carterii Resin Extract, Capsicum Annuum Resin, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Glycerin, Isopropyl Alcohol, Polysorbate 80, Rosmarinus Officinalis (Rosemary) Leaf Oil, Propylene Glycol, 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 label

SCREAMIN MENTHOL TOAST  
menthol cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52099-8010
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX)  
CHAMOMILE (UNII: FGL3685T2X)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
CAPSICUM OLEORESIN (UNII: UW86K581WY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52099-8010-1 141 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part348 06/21/2012
Labeler - Q.A. Laboratories (065361149)
Registrant - Q.A. Laboratories (065361149)
Establishment
Name Address ID/FEI Business Operations
Q.A. Laboratories 065361149 manufacture(52099-8010)

Revised: 11/2012
Document Id: e3e1bce6-42fe-45f2-8f34-a2be39dacbb3
Set id: 91b87879-a3ff-430f-b492-68a60620ab86
Version: 3
Effective Time: 20121106
 
Q.A. Laboratories