Daily Saeroy Hand Care by COSTEM CO.,LTD / ICOMAX Co., Ltd. 75370-020_Deactivation

Daily Saeroy Hand Care by

Drug Labeling and Warnings

Daily Saeroy Hand Care by is a Otc medication manufactured, distributed, or labeled by COSTEM CO.,LTD, ICOMAX Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DAILY SAEROY HAND CARE- benzalkonium chloride gel 
COSTEM 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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75370-020_Deactivation

ACTIVE INGREDIENT

Benzalkonium Chloride 0.06%

INACTIVE INGREDIENTS

Water, Glycerin, Carprylic/Capric Triglyceride, Polysorbate 60, Cetearyl Alcohol, Isopropyl Myristate, Dimethicone, Glyceryl Stearate SE, Sorbitan Sesquioleate, Phenoxyethanol, Carbomer, Triethanolamine, Aloe Extract, Jojoba Oil, Sodium Hyaluronate

PURPOSE

Antiseptic

WARNINGS

For external use only
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Do not use
in children less than 2 months of age
on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Directions

Place enough product on hands to cover all surfaces. Rub hands thoroughly.
Supervise children when using this product to avoid swallowing.

Other information

Store between 1℃-30℃ (33℉-86℉)
Avoid freezing and excessive heat above 40℃ (104F)

Package Label: Daily Saeroy Hand Care (60mL, Tube)

Package Label: Daily Saeroy Hand Care (Carton)

DAILY SAEROY HAND CARE 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75370-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.03 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE (UNII: V5VD430YW9)
JOJOBA OIL (UNII: 724GKU717M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75370-020-02	1 in 1 CARTON	06/01/2020	04/18/2022
1	NDC: 75370-020-01	60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/01/2020	04/18/2022

Labeler - COSTEM CO.,LTD (695673235)

Registrant - COSTEM CO.,LTD (695673235)

Establishment
Name	Address	ID/FEI	Business Operations
reBom Co., Ltd.		688733595	manufacture(75370-020)

Revised: 4/2022

Document Id: dcf1549f-6cb7-7dc9-e053-2995a90a6f08

34390-5

Set id: fd38e1a3-4e3c-4fcc-bc81-45344aa6673f

Version: 3

Effective Time: 20220418