OTC Medication Information: K-pure Hand Sanitizer 70% 500ml

K-PURE HAND SANITIZER 70% 500ML- alcohol gel
Metapola Aroma 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.

Active Ingredient(s)

Ethyl Alcohol 70% v/v

Active Ingredient
(click image for full-size original)

Purpose

Antiseptic

PurposePurpose

Use

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

useuse

Warnings

For external use only. Flammable. Keep away from heat or flame

WarningWarning

Do not use

  • in children less than 2 months of age
  • on open skin wounds

Do not useDo not use

When using this product

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

When usingWhen using

Stop use and ask a doctor

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Stop useStop use

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.

Keep outKeep out

Directions

  • 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.

DirectionDirection

Other information

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

Other informationOther information

Inactive ingredients

Water, Methyl Gluceth-20, PEG-60 Hydrogenated Castor Oil, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Hyaluronic Acid, Aminomethyl Propanol, Fragrance

Inactive ingredientsInactive ingredients

Questions or Comments?

1-800-461-5824

QuestionQuestion

Package Label — Principal Display Panel

K-Pure

HAND

SANITIZER

70% Alcohol

MOISTURIZING FORMULA

VITAMIN E

ALOE VERA

16.9 fl.oz (500ml)

PDPPDP
K-PURE HAND SANITIZER 70% 500ML
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77680-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
WATER
HYALURONIC ACID
PEG-60 HYDROGENATED CASTOR OIL
ALPHA-TOCOPHEROL ACETATE
AMINOMETHYLPROPANOL
METHYL GLUCETH-20
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77680-100-01 500 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 07/14/2020
Labeler — Metapola Aroma Co., Ltd. (690311712)
Establishment
Name Address ID/FEI Operations
Metapola Aroma Co., Ltd 690311712 manufacture (77680-100), label (77680-100)

Revised: 07/2020 Metapola Aroma Co., Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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