FROZEN GRAPE HAND SANITIZER- benzalkonium chloride gel
shenzhen Lantern Science Co. Ltd.

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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Active Ingredient

Benzalkonium Chloride 0.01%

Purpose: Antibacterial

Use

To decrease bacteria on the skin that could cause disease.

Keep out of reach of children.

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.

Directions

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

Inactive Ingredients

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

Frozen Grape Hand Sanitizer

2 FL OZ (59mL)

label

FROZEN GRAPE HAND SANITIZER
benzalkonium chloride gel

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

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

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