ISLAND COTTON- antibacterial hand sanitizer gel 
Brands International Corp

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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Active Ingredient - Ethyl Alcohol 62%

Purpose - Antiseptic

Use

To decrease bacteria on the skin and clean hands
Recommened for repeated use

Warnings

For external use only

Flammable, keep away from fire or flame

Keep out of reach of children

If accidently swallowed, get medical help or contact a Poison Control Center right away

Do not get into eyes

If contact occurs, rinse thoroughly with water

Discontinue use if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor

Directions

Other Information

Inactive Ingredients - Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl (Vitamin E) Acetate, Sunflower (Helianthus Annulus) seed extract, Blue 1 (Cl 42090)

Island Cotton Antibacterial Hand Sanitizer Gel

ISLAND COTTON 
antibacterial hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-117
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mL  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
SUNFLOWER SEED (UNII: R9N3379M4Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50157-117-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product11/02/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/02/2015
Labeler - Brands International Corp (243748238)
Establishment
NameAddressID/FEIBusiness Operations
Brands International Corp243748238manufacture(50157-117)

Revised: 11/2015
Document Id: 3f8ed4b8-0b01-2ebb-e054-00144ff8d46c
Set id: 3f8ed4b8-0b00-2ebb-e054-00144ff8d46c
Version: 1
Effective Time: 20151102
 
Brands International Corp