LABCCIN SANITIZER 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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50375-003_LABCCIN Sanitizer Gel

Active ingredient

Ethyl alcohol 70%

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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.

Direction

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing

Other information

Store below 15-30°C (59-86°F)
Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

Water, Butylene Glycol, Carbomer, Aminomethyl Propanol, Fragrance, Glycerin, Paeonia Suffruticosa Root Extract, Camellia Sinensis Leaf Extract, Aloe Ferox Leaf Extract, CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT

Product Label

LABCCIN SANITIZER GEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50375-003
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE FEROX LEAF (UNII: 0D145J8EME)
GRAPEFRUIT (UNII: O82C39RR8C)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)
PAEONIA X SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50375-003-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020	05/14/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/14/2020	05/14/2020

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Doori Cosmetics Co., Ltd.		688227465	manufacture(50375-003)

Revised: 9/2021

Document Id: cd27245a-9ea3-a682-e053-2a95a90af9fd

Set id: 4e29db0c-5108-4a4c-9ffa-34ea8d98571f

Version: 7

Effective Time: 20210929

Doori Cosmetics Co., Ltd.