CARTE BLANCHE HAND SANIZITER GEL- ethyl alcohol gel 
ORACOS CO LTD.

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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75201-500-01 CARTE BLANCHE HAND SANIZITER GEL

CARTE BLANCHE HAND SANIZITER GEL

CARTE BLANCHE HAND SANIZITER GEL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75201-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75201-500-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/28/2020
Labeler - ORACOS CO LTD. (694463326)
Establishment
NameAddressID/FEIBusiness Operations
EQMAXON Corp.557821534manufacture(75201-500)

Revised: 10/2020
Document Id: b2b4e867-3ad4-fe6c-e053-2995a90a2214
Set id: b2b4e867-3ad3-fe6c-e053-2995a90a2214
Version: 1
Effective Time: 20201028
 
ORACOS CO LTD.