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Flanax by Belmora LLC

Dosage form: liniment
Ingredients: Methyl Salicylate 13.8g in 60mL, Menthol 6g in 60mL, Capsicum Oleoresin 0.014g in 60mL
Labeler: Belmora LLC
NDC Code: 27854-100

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.

Flanax® Liniment

Drug Facts

Active IngredientsPurpose
Methyl Salicylate 23%Topical Analgesic
Menthol 10%Topical Analgesic
Capsaicin 0.014%Topical Analgesic

Uses

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

Warnings

For external use only. Do not use if you are allergic to any of the active or inactive ingredients.

Do not use: on wounds damaged, broken, or irritated skin. With a heating pad. Immediately before or after taking a bath or shower.

Stop use and ask a doctor if: Condition worsens. Symptoms persist for more than 7 days or clear up and occur again within a few days. Skin irritation occurs.

When using this product: Avoid contact with lips, eyes, nose, and any mucous membranes at all times. Do not bandage.

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

Directions

Adults and children 12 years of age and older

Apply to affected area not more than 3-4 times daily. A temporary burning may be felt when applied, but usually disappears with continued use. Wash hands thoroughly after use to avoid spreading liniment to the eyes or other sensitive areas of the body. If applying liniment to the hands wait 30 minutes before washing hands. Initial pain relief is usually noted within 1-2 weeks. If condition does not improve in 4 weeks discontinue use of this product.

Children under 12 years of age

consult doctor before use.

Other Information

Store at room temperature. To open press down on cap of bottle.

Inactive Ingredients

cetearyl alcohol 30/70 NF, cetyl esters NF, glyceryl stearate, ceteareth 20, castor oil, propylparaben, purified water.

Questions/Comments

Distributed by Belmora LLC
PO Box 3063, Arlington, VA 22203
1-888-535-2629 www.flanaxusa.com

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

FLANAX 
methyl salicylate, menthol, and capsicum oleoresin liniment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Methyl Salicylate (Salicylic Acid) Methyl Salicylate13.8 g  in 60 mL
Menthol (Menthol) Menthol6 g  in 60 mL
Capsicum Oleoresin (Capsicum Oleoresin) Capsicum0.014 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL 
CETYL ESTERS WAX 
GLYCERYL MONOSTEARATE 
POLYOXYL 20 CETOSTEARYL ETHER 
CASTOR OIL 
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:27854-100-0360 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34812/06/201210/01/2018
Labeler - Belmora LLC (112753244)
Registrant - Cosmetics & Cleaners International, LLC. dba C&C Industries (018949897)
Establishment
NameAddressID/FEIOperations
Cosmetics & Cleaners International, LLC. dba C&C Industries018949897LABEL(27854-100), manufacture(27854-100)

Revised: 10/2016
 
Belmora LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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