K-PURE by NIBEC Co., Ltd.

K-PURE by

Drug Labeling and Warnings

K-PURE by is a Otc medication manufactured, distributed, or labeled by NIBEC Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

K-PURE- alcohol gel 
NIBEC 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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Ethyl alcohol 70% v/v

Antimicrobial

Hand sanitizer to help reduce bacteria on the skin

Recommended for repeated use.

Flammable. Keep away from fire or flame.

For external use only.

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

Stop use and ask a doctorif 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.

Keep out of reach of children.

For external use only.

• Place enough product in your palm to cover your hands.
• Rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using this product.

• Store at room temperature [33.8 ~ 86°F (1 ~ 30°C)]
• May discolor certain fabrics or surfaces

Purified Water, Aloe Vera Gel, Glycerin, Isopropyl Alcohol, Carbopol 980, Edetol

Drug Facts

K-PURE 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47649-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	73.68 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EDETOL (UNII: Q4R969U9FR)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47649-0003-4	24 in 1 BOX	06/10/2020
1	NDC: 47649-0003-1	30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 47649-0003-2	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2020
3	NDC: 47649-0003-3	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/10/2020	09/13/2023

Labeler - NIBEC Co., Ltd. (687796909)

Establishment
Name	Address	ID/FEI	Business Operations
NIBEC Co., Ltd.		687796909	manufacture(47649-0003)

Revised: 9/2023

Document Id: 05484381-1ecd-388b-e063-6394a90aa378

34390-5

Set id: a7b4e528-fe49-6db6-e053-2995a90af198

Version: 3

Effective Time: 20230913