ISLAND COTTON- antibacterial hand sanitizer gel

Island Cotton by

Drug Labeling and Warnings

Island Cotton by is a Otc medication manufactured, distributed, or labeled by Brands International Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient - Ethyl Alcohol 62%

PURPOSE

Purpose - Antiseptic

INDICATIONS & USAGE

Use

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

WARNINGS

Warnings

For external use only

Flammable, keep away from fire or flame

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

SAFE HANDLING WARNING

Do not get into eyes

If contact occurs, rinse thoroughly with water

ASK DOCTOR

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

DOSAGE & ADMINISTRATION

Directions

• apply to hands until thoroughly wet
• rub vigorously until dry
• supervise children in the use of this product

OTHER SAFETY INFORMATION

Other Information

• May discolour certain fabrics or surfaces
• do not store above 110 F (43 C)

INACTIVE INGREDIENT

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ISLAND COTTON 
antibacterial hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50157-117
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	620 mL  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50157-117-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/02/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/02/2015

Labeler - Brands International Corp (243748238)

Establishment
Name	Address	ID/FEI	Business Operations
Brands International Corp		243748238	manufacture(50157-117)