CLEAN HAND SANITIZER- ethyl alcohol spray 
Bicooya Cosmetics Limited

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.

----------

Drug Facts

Active Ingredient

Ethyl Alcohol 62%

Purpose
Antiseptic

Uses • sanitizer spray to help decrease bacteria on the skin

         •recommended for repeated use.

Warnings •Flammable. • Keep away from fire or flame. •For external use only

When using this product •avoid contact with eyes • in case of contact, rinse eyes throughtly with water

•do not apply around eyes, do not use near the eyes and mouth.

Keep out of reach of children. if sweallowede, get medical help or contact a Poison Control Center right away.

Other information • do not store above 105F. May discolor some fabrics.

Directions • spray enough product in your palms and thoroughly spread on both hands and rub into skin until dry.

Inactive ingredients aloe barbadensis gel, carbomer, fragrance, FD&C blue no. 1, FD&C yellow no.5, glycerin, isopropyl alcohol, PEG-40 hydrogenated castor oil, propylene glycol, triethanolamine, water

Package Label

image of package label

CLEAN HAND SANITIZER 
ethyl alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58180-210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58180-210-0110 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/09/2014
Labeler - Bicooya Cosmetics Limited (421310774)
Registrant - Bicooya Cosmetics Limited (421310774)
Establishment
NameAddressID/FEIBusiness Operations
Bicooya Cosmetics Limited421310774manufacture(58180-210)

Revised: 12/2014
Document Id: d7d08a8a-5c5e-40a2-a2de-cae21477127d
Set id: ae692bf3-70ef-46ef-9c55-395d70eb42ae
Version: 1
Effective Time: 20141209
 
Bicooya Cosmetics Limited