QUICK-DRYING HAND SANITIZER- hand sanitizer liquid
Shandong Kehong Medical Technology 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.

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Active Ingredient(s)

Isopropyl Alcohol 75%,Chlorhexidine Gluconate 1.1%

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

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

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.

Other information

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

Inactive ingredients

water

Packaging Labels - Main Display Panel

kh1

QUICK-DRYING HAND SANITIZER
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75244-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	1.1 g in 100 g
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75244-001-01	100 g in 1 BOTTLE; Type 0: Not a Combination Product	04/14/2020
2	NDC:75244-001-02	500 g in 1 BOTTLE; Type 0: Not a Combination Product	04/14/2020
3	NDC:75244-001-03	1000 g in 1 BOTTLE; Type 0: Not a Combination Product	04/14/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/14/2020

Labeler - Shandong Kehong Medical Technology Co.,Ltd. (554527496)

Name	Address	ID/FEI	Business Operations
Establishment
Shandong Kehong Medical Technology Co.,Ltd		554527496	manufacture(75244-001)