SooAe Hand Sanitizing Wipes by FIRSTCHAM CO., LTD

SooAe Hand Sanitizing Wipes by

Drug Labeling and Warnings

SooAe Hand Sanitizing Wipes by is a Otc medication manufactured, distributed, or labeled by FIRSTCHAM CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SOOAE HAND SANITIZING WIPES- benzalkonium chloride cloth 
FIRSTCHAM 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%

INACTIVE INGREDIENTS

Water (Aqua), Phenoxyethanol, Glycerin, Sodium benzoate, Polysorbate 20, Disodium EDTA, Citric Acid, Tocopheryl Acetate

PURPOSE

Antiseptic

handwash

WARNINGS

For external use only

Do not use
■ If you are allergic to any of the ingredients

When using this product
■ Do not get into eyes. If contact occurs, rinse thoroughly with water

Stop use and ask a doctor if
■ Irritation or rash develops and continues for more than 72 hours

Keep out of reach of children
■ Unless under adult supervision
■ If swallowed, get medical help or contact a Poison Control Center right away

KEEP OUT OF REACH OF CHILDREN

■ Unless under adult supervision
■ If swallowed, get medical help or contact a Poison Control Center right away

Uses

■ For hand washing to decrease bacteria on the skin

Directions

■ Use entire wipe to thoroughly wipe hands, fingers, and wrists
■ To sanitize, use multiple wipes
■ Discard after single use
■ Keep label closed to prevent moisture loss

Other information

■ Read the directions and warnings before use
■ Avoid freezing and excessive heat

Questions or Comments?

■ E-mail: cs@dkcos.com
■ Call 1-212-484-2621

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SOOAE HAND SANITIZING WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73923-0150
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73923-0150-1	20 in 1 PACKET; Type 0: Not a Combination Product	12/01/2021	01/10/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/01/2021	01/10/2022

Labeler - FIRSTCHAM CO., LTD (689905446)

Registrant - FIRSTCHAM CO., LTD (689905446)

Establishment
Name	Address	ID/FEI	Business Operations
FIRSTCHAM CO., LTD		694707327	manufacture(73923-0150)

Revised: 1/2022

Document Id: 3e97abfb-a6b4-4a91-aca6-081a92292906

34390-5

Set id: ab7dd5a0-70a8-4b3a-a0e9-bd15060eac1a

Version: 2

Effective Time: 20220114