VANILLA 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 0.1%

Antibacterial

Keep out of reach of children.

Warnings

for external use only
if irritation occurs discontinue use
keep out of eyes
avoid contact with broken skin
do not inhale or ingest
stop use and ask if doctor if skin irritation develops
keep out of reach of children
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, hydroxyethylcellulose, phenoxyethanol, fragrance/parfum, disodium edta

To decrease bacteria on hands

label

VANILLA HAND SANITIZER
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54860-089
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
HYDROXYETHYL ETHYLCELLULOSE (UNII: ZDN57Z154K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54860-089-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/30/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/30/2018

Labeler - Shenzhen Lantern Science Co., Ltd. (421222423)

Name	Address	ID/FEI	Business Operations
Establishment
Shenzhen Lantern Science Co., Ltd.		421222423	manufacture(54860-089)