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

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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.

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