FROZEN GRAPE HAND SANITIZER- benzalkonium chloride gel

Frozen Grape Hand Sanitizer by

Drug Labeling and Warnings

Frozen Grape Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by shenzhen Lantern Science Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Benzalkonium Chloride 0.01%



Purpose: Antibacterial

PURPOSE

Use

To decrease bacteria on the skin that could cause disease.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

WARNINGS

Warnings

• for external use only-hands.
• keep out of eyes. avoid contact with broken skin.
• stop use and ask a Doctor if irritation or redness develops.
• do not inhale or ingest. if swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION

Directions

• Rub a dime sized drop into hands.
• For children under 6 use under adult supervision.

INACTIVE INGREDIENT

Inactive Ingredients

water (aqua/eau), coceth-7, PPG-1-PEG-9 lauryl glycol ether, triethanolamine, PEG-40 hydrogenated castor oil, chloropropylate, fragrance (parfum).

INDICATIONS & USAGE

Frozen Grape Hand Sanitizer

2 FL OZ (59mL)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FROZEN GRAPE HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54860-034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.01 g  in 59 g

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCETH-7 CARBOXYLIC ACID (UNII: 35KO064932)
CHLOROPROPYLATE (UNII: GI03ROM7HQ)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54860-034-01	59 g in 1 BOTTLE; Type 0: Not a Combination Product	06/13/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/13/2016

Labeler - shenzhen Lantern Science Co. Ltd. (421222423)

Establishment
Name	Address	ID/FEI	Business Operations
shenzhen Lantern Science Co. Ltd.		421222423	manufacture(54860-034)