Dongil Hand Cleaner Hand Sanitizer: Package Insert and Label Information

DONGIL HAND CLEANER HAND SANITIZER- alcohol gel
DONG IL PHARMS 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

Alcohol 70% v/v

INACTIVE INGREDIENTS

Glycerin, Chamomile Extract, Carbomer, Triethanolamine, Water

PURPOSE

Antiseptic

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

■ Hand sanitizer to help reduce bacteria that potentially can cause disease.

WARNINGS

For external use only. Keep away from heat or frame. Flammable.
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Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Directions

■ Sprinkle a suitable amount on your hand and rub it well to dry it.

Other information

■ Store between 0-30C (32-86F)
■ Avoid freezing and excessive heat above 40C (104F)

QUESTIONS

+82-43-877-2132~3
http://www.dipharms.co.kr/

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DONGIL HAND CLEANER HAND SANITIZER alcohol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73242-0150 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 350 mL in 500 mL

Inactive Ingredients Ingredient Name Strength CHAMOMILE TROLAMINE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE GLYCERIN WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73242-0150-1 500 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 04/20/2020

Labeler — DONG IL PHARMS CO., LTD. (557810721)

Registrant — DONG IL PHARMS CO., LTD. (557810721)

Establishment
Name	Address	ID/FEI	Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture (73242-0150)

Revised: 11/2020 DONG IL PHARMS CO., LTD.