PCXX MINUTE FM LIME- sodium fluoride aerosol, foam 
Ross Healthcare Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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APF FM LM front panel

APF FM LM secondary panel

PCXX MINUTE FM LIME 
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-270
Route of Administrationtopical
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION.0272 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) .04 g  in 1 g
SODIUM LAURYL SULFATE (UNII: 368GB5141J) 1.2 mg  in 1 g
HYDROFLUORIC ACID (UNII: RGL5YE86CZ) 8.5 mg  in 1 g
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) .011 g  in 1 g
XANTHAN GUM (UNII: TTV12P4NEE) 4.2 mg  in 1 g
Product Characteristics
Color    Score    
ShapeSize
FlavorLIMEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62007-270-07125 g in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/03/2015
Labeler - Ross Healthcare Inc. (244249012)
Registrant - Ross Healthcare Inc. (244249012)
Establishment
NameAddressID/FEIBusiness Operations
Ross Healthcare Inc.244249012manufacture(62007-270)

Revised: 2/2015
Document Id: 249014b9-3461-4eb8-a2ef-2375d8d7ba05
Set id: 256fb795-b022-41bc-b3b0-d7dc6dca1730
Version: 1
Effective Time: 20150203
 
Ross Healthcare Inc.