KLEEN HAND SANITIZER- alcohol gel

KLEEN HAND SANITIZER by

Drug Labeling and Warnings

KLEEN HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by 79741, SAIGON COSMETICS CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol 70% v/v Purpose: Antiseptic

PURPOSE

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE

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

WARNINGS

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

DO NOT USE

Do not use

• In children without aldult supervision
• On open skin wound

WHEN USING

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

STOP USE

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

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.

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

Other information:

• Store between 15-25oC (59-77oF)
• Avoid freezing and excessive heat above 40oC (104oF)

INACTIVE INGREDIENT

Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked), Propylene Glycol, Trolamine, Water

QUESTIONS

+84-28-3742-1102

PRINCIPAL DISPLAY PANEL

Kleen Hand Sanitizer 90mL

Kleen Hand Sanitizer 100mL

Kleen Hand Sanitizer 250mL

Kleen Hand Sanitizer 320mL

Kleen Hand Sanitizer 500mL

INGREDIENTS AND APPEARANCE

KLEEN HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79741-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79741-000-50	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/25/2020
2	NDC: 79741-000-32	320 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/25/2020
3	NDC: 79741-000-10	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/25/2020
4	NDC: 79741-000-09	90 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/25/2020
5	NDC: 79741-000-25	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/25/2020

Labeler - 79741 (555265180)

Registrant - SAIGON COSMETICS CORPORATION (555265180)

Establishment
Name	Address	ID/FEI	Business Operations
SAIGON COSMETICS CORPORATION		555265180	manufacture(79741-000)