SWIRLING LOLLIPOP- antibacterial hand sanitizer gel gel

SWIRLING LOLLIPOP by

Drug Labeling and Warnings

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

Drug Details [pdf]

PACKAGE LABEL

SWIRLING LOLLIPOP

ANTIBACTERIAL

Hand Sanitizer Gel

Kills 99.99% of Germs

1 FL OZ (29ml)

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: Ethyl Alcohol 62%

PURPOSE

Antiseptic

INDICATIONS & USAGE

Use

• To decrease bacteria on the skin and clean hands.
• Recommended 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 accidentally swallowed get medical help or contact a Poison Control Center right away.

WHEN USING

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

• may discolor certain fabrics or surfaces
• do not store above 110ºF (43ºC)

INACTIVE INGREDIENT

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)

INGREDIENTS AND APPEARANCE

SWIRLING LOLLIPOP 
antibacterial hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50157-114
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50157-114-01	29 mL in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	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(50157-114)