K-PURE: Package Insert and Label Information

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.

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 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.

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 fact
(click image for full-size original)

K-PURE
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47649-0003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 73.68 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
EDETOL
ISOPROPYL ALCOHOL
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
GLYCERIN
WATER
ALOE VERA LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47649-0003-4 24 BOTTLE in 1 BOX contains a BOTTLE (47649-0003-1)
1 NDC:47649-0003-1 30 mL in 1 BOTTLE This package is contained within the BOX (47649-0003-4)
2 NDC:47649-0003-2 250 mL in 1 BOTTLE None
3 NDC:47649-0003-3 500 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/10/2020
Labeler — NIBEC Co., Ltd. (687796909)
Establishment
Name Address ID/FEI Operations
NIBEC Co., Ltd. 687796909 manufacture (47649-0003)

Revised: 01/2021 NIBEC Co., Ltd.

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