50375-004_Dooricare Pure Hand Gel

Dooricare Pure Hand gel by

Drug Labeling and Warnings

Dooricare Pure Hand gel by is a Otc medication manufactured, distributed, or labeled by Doori Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOORICARE PURE HAND GEL- alcohol gel 
Doori Cosmetics 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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50375-004_Dooricare Pure Hand Gel

Active ingredient

Ethyl alcohol 70%

Purpose

Antimicrobial

Use

• Hand sanitizer to help reduce bacteria on the skin

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.

Stop use and ask a doctor if irritation or rash appears and lasts

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

Directions

• Put nough produt in your palm to cover hands and rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using this product

Other information

• Store below 110°F (43°C)
• May discolor certain fabrics or surfaces

Inactive ingredients

Water, Butylene Glycol, Carbomer, Aminomethyl Propanol, Fragrance, Glycerin, Camellia Sinensis Leaf Extract, Aloe Ferox Leaf Extract, Camellia Sinensis Leaf/Stem Extract

DOORICARE PURE HAND GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50375-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE FEROX LEAF (UNII: 0D145J8EME)
CENTELLA ASIATICA ROOT (UNII: 8MXU1P42J0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50375-004-01	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/30/2020	07/30/2020
2	NDC: 50375-004-02	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/30/2020	07/30/2020
3	NDC: 50375-004-03	50 mL in 1 TUBE; Type 0: Not a Combination Product	07/30/2020	07/30/2020
4	NDC: 50375-004-04	70 mL in 1 TUBE; Type 0: Not a Combination Product	07/30/2020	07/30/2020
5	NDC: 50375-004-05	100 mL in 1 TUBE; Type 0: Not a Combination Product	07/30/2020	07/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/30/2020	07/30/2020

Labeler - Doori Cosmetics Co., Ltd. (688227465)

Registrant - Doori Cosmetics Co., Ltd. (688227465)

Establishment
Name	Address	ID/FEI	Business Operations
Doori Cosmetics Co., Ltd.		688227465	manufacture(50375-004)

Revised: 9/2021

Document Id: cd272717-c895-0b9b-e053-2995a90a1a0a

34390-5

Set id: a1d6a52c-2755-455e-93dc-a74ce45e047e

Version: 6

Effective Time: 20210929