ikoo care hand sanitizing sheets by BEAUTY-LAB LLC / FIRSTCHAM CO., LTD

ikoo care hand sanitizing sheets by

Drug Labeling and Warnings

ikoo care hand sanitizing sheets by is a Otc medication manufactured, distributed, or labeled by BEAUTY-LAB LLC, FIRSTCHAM CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IKOO CARE HAND SANITIZING SHEETS- benzalkonium chloride cloth 
BEAUTY-LAB LLC

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%

INACTIVE INGREDIENTS

Citric acid, Disodium EDTA, Glycerin, Phenoxyethanol, Polysorbate 20, Sodium Benzoate, Tocopheryl acetate, Water(Aqua)

PURPOSE

Antiseptic

WARNINGS

For external use only
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Stop use and ask a doctor if
■ hypersensitivity, skin irritation, or rash develops and persists
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Do not use
■ in combination with soap or antibacterial cleansing agents
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When using this product
■ avoid using repeatedly in the same area as skin irritation may occur
■ avoid getting into the eyes (if contact occurs, wash well with clean water)
■ if the following abnormal symptoms persist (irritation around the eyes, ears, mucous membranes, including the mouth, and skin rashes), discontinue use

KEEP OUT OF REACH OF CHILDREN

■ Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

■ Hand antiseptic to reduce bacteria that can potentially cause disease
■ Instant antiseptic to decrease bacteria on the skin

Directions

■ Take a sheet from the package (more if needed), wipe hands and skin thoroughly, then let dry completely.

Other Information

■ Read the directions and warnings before use
■ Avoid freezing and excessive heat above 40℃(104℉)

Questions?

+ 1 (469) 676 9468

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IKOO CARE HAND SANITIZING SHEETS 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80473-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	0.001 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
Glycerin (UNII: PDC6A3C0OX)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polysorbate 20 (UNII: 7T1F30V5YH)
Sodium Benzoate (UNII: OJ245FE5EU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80473-010-01	80 in 1 PACKET; Type 0: Not a Combination Product	09/01/2020	12/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2020	12/01/2021

Labeler - BEAUTY-LAB LLC (053878473)

Registrant - BEAUTY-LAB LLC (053878473)

Establishment
Name	Address	ID/FEI	Business Operations
FIRSTCHAM CO., LTD		689905446	manufacture(80473-010)

Revised: 9/2022

Document Id: 1859ab3f-5eef-49a5-aa22-4af3c266ece0

34390-5

Set id: db6dfd0d-930b-4322-bf6e-a130bde52169

Version: 3

Effective Time: 20220908