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QUICKFLEX (menthol) cream
[Access Business Group International LLC]


NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

Active Ingredient

Menthol 1.25%

Purpose

Pain relieving cream

Use

Temporarily relieves minor aches and pains of muscles
and joints associated with:
simple backache
arthritis
strains
bruises
sprains

Warnings

For external use only

Do not use

on wounds or damaged skin

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

Keep out of reach of children


Directions

  • Adult 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 physician.

Inactive Ingredients

aloe vera gel, cetyl alcohol, cetyl esters, cinnamon oil, eucalyptus oil, glyceryl stearate, grape seed oil, hypromellose, jojoba oil, peppermint oil, potassium sorbate, purified water, squalane, stearic acid, stearyl alcohol, tea tree oil, vegetable glycerin, wintergreen oil.

PRINCIPAL DISPLAY PANEL

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INGREDIENTS & APPEARANCE

QUICKFLEX 
menthol cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:10056-135
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL1.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CETYL ALCOHOL 
CINNAMON OIL 
EUCALYPTUS OIL 
GLYCERYL MONOSTEARATE 
HYPROMELLOSE 
PEPPERMINT OIL 
POTASSIUM SORBATE 
WATER 
SQUALANE 
STEARIC ACID 
STEARYL ALCOHOL 
GLYCERIN 
GRAPE SEED OIL 
JOJOBA OIL 
TEA TREE OIL 
METHYL SALICYLATE 
CETYL ESTERS WAX 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10056-135-0185 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/30/2010
Labeler - Access Business Group International LLC (609682641)

Revised: 7/2010
 
Access Business Group International LLC