SWIRLING LOLLIPOP- antibacterial hand sanitizer gel 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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PACKAGE LABEL

SWIRLING LOLLIPOP

ANTIBACTERIAL

Hand Sanitizer Gel

Kills 99.99% of Germs

1 FL OZ (29ml) product label

ACTIVE INGREDIENTS: Ethyl Alcohol 62%

Antiseptic

Use

Warnings

For external use only.

Flammable, keep away from fire or flame.

Keep out of reach of children. If accidentally 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

Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl (Vitamin E) Acetate, Sunflower (Helianthus Annuus) Seed Extract, Yellow 5 (Cl 19140), Blue 1 (Cl 42090)

SWIRLING LOLLIPOP 
antibacterial hand sanitizer gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-114
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
CARBOMER 940 (UNII: 4Q93RCW27E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SUNFLOWER SEED (UNII: R9N3379M4Z)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
GLYCERIN (UNII: PDC6A3C0OX)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50157-114-0129 mL in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)11/02/2015
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(50157-114)

Revised: 11/2015
Document Id: 2346dcb3-f1ba-6ba8-e054-00144ff8d46c
Set id: 2346dcb3-f1b9-6ba8-e054-00144ff8d46c
Version: 1
Effective Time: 20151102
 
Brands International Corp