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Island Cotton

Medically reviewed on Nov 2, 2017

Dosage form: gel
Ingredients: ALCOHOL 620mL in 1000mL
Labeler: Brands International Corp
NDC Code: 50157-117

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.

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

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

Other Information

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

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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-117
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL620 mL  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL ALCOHOL 
GLYCERIN 
PROPYLENE GLYCOL 
ISOPROPYL MYRISTATE 
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
FD&C BLUE NO. 1 
CARBOMER 940 
AMINOMETHYLPROPANOL 
SUNFLOWER SEED 
Packaging
#Item CodePackage Description
1NDC:50157-117-0129 mL in 1 BOTTLE
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/FEIOperations
Brands International Corp243748238manufacture(50157-117)

 
Brands International Corp

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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