FLEX POWER CREAM - glycerin cream 
FLEX-POWER KOREA INC

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.

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Drug Facts

glycerin

water, isopropyl palmitate, butylene glycol, stearic acid, glyceryl stearate, cetyl alcohol, polysorbate 61, witch hazel ext, butylene glycol, pentylene glycol, petrolatum, peg-101 stearate, dimethicone, cetyl ethylhexanoate, vanillyl butyl ether, squalane, triethanolamine, carbomer, lactic acid, xanthan gum, dimethyl sulfone, acetyl glucosamine, paeonia suffruticosa root ext, scutellaria baicalensis root ext, cetyl pyridinium chloride, sodium dehydroacetate, hexylene glycol, beeswax, fragrance, disodium edta, tocopheryl acetate, hydrogenated lecithin, ceramide 4, tea-cocoyl glutamate, caprylic/capric triglyceride, cholesterol


endless effort to improve performance and passion for healthy lifestyle

keep out of reach of the children


massage on body for warming sensation
use apply gradually to build comfort level for warming sensation


use only as directed
avoid contact with eyes, face, wounds, damaged skin or sensitive areas. if contact occurs, flush with water for 15 minutes


for external use only


package insert
FLEX POWER CREAM 
glycerin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69093-1001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69093-1001-1100 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/03/2014
Labeler - FLEX-POWER KOREA INC (688413457)
Registrant - FLEX-POWER KOREA INC (688413457)
Establishment
NameAddressID/FEIBusiness Operations
FLEX-POWER KOREA INC688413457manufacture(69093-1001)

Revised: 7/2014
Document Id: af6bc443-664b-4fbc-878b-bc1a724eeb7d
Set id: a2b9c324-a0c4-4fb7-ad2f-ad33783fd04c
Version: 1
Effective Time: 20140704
 
FLEX-POWER KOREA INC