DS HANCLE ANTISEPTIC HAND SANITIZER- ethyl alcohol gel

DS Hancle Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

DS Hancle Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by DongSung Pharm Co., Ltd., Dong Sung World Wide USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 62%. Purpose: Antiseptic

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria on the skin. (Gel Type)

Warnings

Flammable, keep away from fire or flame.

For external use only.

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

ASK DOCTOR

Stop use and ask a doctor if irritation or rash develops and lasts.

KEEP OUT OF REACH OF CHILDREN

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

Directions

▪ Pump enough product in your palm to cover hands and briskly rub your hands together until dry.

▪ Children under 6, use only under adult supervision.

Other Information

Store below 86°F/ 30°C.

Inactive Ingredients

Water(aqua), Methyl Gluceth-20, Acrylic Acid-Alkyl Methacrylate Copolymer, Triethanolamine, Tocopheryl Acetate, Melaleuca Alternifolia (Tea Tree) Leaf Oil

Questions?

562-802-0131 / www.dseshopusa.com

PRINCIPAL DISPLAY PANEL

300 mL, NDC: 42361-071-01

PRINCIPAL DISPLAY PANEL

50 mL, NDC: 42361-071-02

PRINCIPAL DISPLAY PANEL

300 mL, NDC: 42361-071-03

PRINCIPAL DISPLAY PANEL

300 mL, NDC: 42361-071-04

INGREDIENTS AND APPEARANCE

DS HANCLE ANTISEPTIC HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42361-071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
TEA TREE OIL (UNII: VIF565UC2G)
TROLAMINE (UNII: 9O3K93S3TK)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42361-071-01	1 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/03/2020	04/11/2020
2	NDC: 42361-071-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/03/2020
3	NDC: 42361-071-03	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/03/2020
4	NDC: 42361-071-04	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/03/2020

Labeler - Dong Sung Bio Pharm. Co., Ltd. (687811661)

Registrant - Dong Sung World Wide USA, Inc. (784969219)

Establishment
Name	Address	ID/FEI	Business Operations
Dong Sung Bio Pharm. Co., Ltd.		687811661	label(42361-071)

Establishment
Name	Address	ID/FEI	Business Operations
DONG SUNG BIO PHARM.CO.,LTD._Asan Factory		687856557	manufacture(42361-071) , pack(42361-071)