ikoo care hand sanitizer by BEAUTY-LAB LLC / ANCORS CO., LTD.

ikoo care hand sanitizer by

Drug Labeling and Warnings

ikoo care hand sanitizer by is a Otc medication manufactured, distributed, or labeled by BEAUTY-LAB LLC, ANCORS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IKOO CARE HAND SANITIZER- alcohol gel 
BEAUTY-LAB LLC

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

Alcohol 62% v/v

INACTIVE INGREDIENTS

WATER, GLYCERIN, BUTYLENE GLYCOL, CARBOMER, AMINOMETHYL PROPANOL, 1,2-HEXANEDIOL, ALOE BARBADENSIS LEAF EXTRACT

PURPOSE

Antiseptic

WARNINGS

Flammable. Keep away from fire or flame.
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For external use only.
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Do not use
■ on children less than 2 months of age.
■ on open skin wounds.
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When using this product
■ do not get into eyes.
■ if contact occurs, rinse thoroughly with water.

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Stop use and ask a doctor if
■ irritation and redness develop. These may be signs of a serious condition.

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.

Uses

■ Hand sanitizer to help decrease bacteria on the skin when water, soap, and towel are not available.
■ Recommended for repeat use.

Directions

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

Other Information

■ Store between 15~30℃(59~86℉).
■ Avoid freezing and excessive heat above 40℃(104℉).

Questions?

+ 1 (469) 676 9468

Package Label: ikoo care hand sanitizer gel (1000mL)
NDC: 80473-020-02

IKOO CARE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80473-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	Alcohol	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80473-020-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020	12/01/2021
2	NDC: 80473-020-02	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020	12/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2020	12/01/2021

Labeler - BEAUTY-LAB LLC (053878473)

Registrant - BEAUTY-LAB LLC (053878473)

Establishment
Name	Address	ID/FEI	Business Operations
ANCORS CO., LTD.		688494804	manufacture(80473-020)

Revised: 9/2022

Document Id: ab50fbd3-eb10-4635-b9c6-83c5db1617d5

34390-5

Set id: f0a6dca1-7554-421f-8ba6-e27e23bc090c

Version: 2

Effective Time: 20220908