K.Boeun Hand Sanitizer: Package Insert and Label Information

K.BOEUN HAND SANITIZER- alcohol gel
K.Boeun Pharmaceutical 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.

Alcohol

Water, Carbomer, Triethanolamine, etc.

Antiseptic

KEEP OUT OF REACH OF THE CHILDREN

Store under 30°C (86°F)

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Apply proper amount to the palm or hands.

1

K.BOEUN HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74724-0002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74724-0002-1 500 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/01/2020
Labeler — K.Boeun Pharmaceutical Co.,Ltd. (695674074)
Registrant — K.Boeun Pharmaceutical Co.,Ltd. (695674074)
Establishment
Name Address ID/FEI Operations
K.Boeun Pharmaceutical Co.,Ltd. 695674074 manufacture (74724-0002)

Revised: 04/2020 K.Boeun Pharmaceutical Co.,Ltd.

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