LITE N FOAMY NON-ALCOHOL HAND SANITIZER- lite n foamy non-alcohol hand sanitizer soap
Spartan Chemical Company

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% w/w

Purpose

Antiseptic

Use

For hand sanitizing to decrease bacteria on the skin
Recommended for repeated use

Warnings

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation and redness develops, if condition persists for more than 72 hours consult a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Warnings Section

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

Directions

Pump a small amount of foam into palm of hand

Rub thoroughly over all surfaces of both hands

Rub hands together briskly until dry

Inactive Ingredients

Water, Cocomidopropyl PG-Dimonium Chloride Phosphate, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Citric Acid, Fragrance

Questions?

1-800-537-8990

18oz Label

Gallon Label

LITE N FOAMY NON-ALCOHOL HAND SANITIZER
lite n foamy non-alcohol hand sanitizer soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64009-222
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 g in 1000 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
FRAGRANCE 13576 (UNII: 5EM498GW35)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64009-222-85	3790 g in 1 CONTAINER; Type 0: Not a Combination Product	12/31/2022
2	NDC:64009-222-88	208200 g in 1 CONTAINER; Type 0: Not a Combination Product	12/31/2022
3	NDC:64009-222-82	532 g in 1 CONTAINER; Type 0: Not a Combination Product	12/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	12/31/2022

Labeler - Spartan Chemical Company (005036728)

Name	Address	ID/FEI	Business Operations
Establishment
Spartan Chemical Company		005036728	manufacture(64009-222)

Revised: 11/2022

Document Id: ee8be683-f936-b32b-e053-2995a90aa51f

Set id: ee8be683-f935-b32b-e053-2995a90aa51f

Version: 1

Effective Time: 20221128

Spartan Chemical Company