KLEEN HAND SANITIZER RELAXING LAVENDER- acohol gel

KLEEN HAND SANITIZER RELAXING LAVENDER by

Drug Labeling and Warnings

KLEEN HAND SANITIZER RELAXING LAVENDER by is a Otc medication manufactured, distributed, or labeled by 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.

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

.Alpha.-terpinyl acetate, (+/-)-, .Beta.-pinene, .Beta.-caryophyllene oxide, 1-Octen-3-ol, 1-Octen-3-yl acetate, 3,5,5-Trimethylhexyl acetate, 3-Carene, 4-Terpineol, (+/-)-,4-Tert-butylcyclohexyl acetate, Benzoic acid, Butylated hydroxytoluene, Camphene, Camphor (synthetic), Carbomer interpolymer type a (allyl sucrose crosslinked), Caryophyllene, Coumarin, Dihydromyrcenol, Diphenyl ether, Eucalyptol, Geraniol, Geranyl acetate, Hexamethylindanopyran, Limonene, (+)-, Linalool, (+/-)-, Linalyl acetate, (+)-,Musk ketone, Nerol, Neryl acetate, P-cymene, Pinene, Polyoxyl 40 hydrogenated castor oil, Propylene glycol, Terpineol, Terpinolene, Trolamine, Water.

QUESTIONS

+84-28-3742-1102

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KLEEN HAND SANITIZER RELAXING LAVENDER 
acohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79741-004
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
HEXAMETHYLINDANOPYRAN (UNII: 14170060AT)
3-CARENE (UNII: H2M15SNR6N)
.BETA.-CARYOPHYLLENE OXIDE (UNII: S2XU9K448U)
WATER (UNII: 059QF0KO0R)
CAMPHENE (UNII: G3VG94Z26E)
COUMARIN (UNII: A4VZ22K1WT)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
DIPHENYL ETHER (UNII: 3O695R5M1U)
4-TERPINEOL, (+/-)- (UNII: L65MV77ZG6)
4-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 21EUM2B8UC)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
1-OCTEN-3-YL ACETATE (UNII: 2PZ32LCA02)
.BETA.-PINENE (UNII: 4MS8VHZ1HJ)
GERANYL ACETATE (UNII: 3W81YG7P9R)
TERPINOLENE (UNII: N9830X5KSL)
PINENE (UNII: 996299PUKB)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
LINALYL ACETATE, (+)- (UNII: 3ID3M89AV9)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TROLAMINE (UNII: 9O3K93S3TK)
BENZOIC ACID (UNII: 8SKN0B0MIM)
1-OCTEN-3-OL (UNII: WXB511GE38)
NEROL (UNII: 38G5P53250)
NERYL ACETATE (UNII: OF82IJU18H)
P-CYMENE (UNII: 1G1C8T1N7Q)
.ALPHA.-TERPINYL ACETATE, (+/-)- (UNII: 9RXE0I9F2J)
DIHYDROMYRCENOL (UNII: 46L1B02ND9)
EUCALYPTOL (UNII: RV6J6604TK)
3,5,5-TRIMETHYLHEXYL ACETATE (UNII: 9HMD71U17Z)
GERANIOL (UNII: L837108USY)
MUSK KETONE (UNII: 483V3E1L6J)
CARYOPHYLLENE (UNII: BHW853AU9H)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TERPINEOL (UNII: R53Q4ZWC99)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79741-004-09	90 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2020
2	NDC: 79741-004-10	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2020
3	NDC: 79741-004-25	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/15/2020
4	NDC: 79741-004-32	320 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/15/2020
5	NDC: 79741-004-50	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/15/2020

Labeler - SAIGON COSMETICS CORPORATION (555265180)

Registrant - SAIGON COSMETICS CORPORATION (555265180)

Establishment
Name	Address	ID/FEI	Business Operations
SAIGON COSMETICS CORPORATION		555265180	manufacture(79741-004)