KLEEN HAND SANITIZER MANGO- alcohol gel 
SAIGON COSMETICS CORPORATION

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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Alcohol 70% v/v purpose: antiseptic

Antiseptic, hand sanitizer

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

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

Do not use

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 serious conditions.

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:

+84-28-3742-1102

.Alpha.-hexylcinnamaldehyde, .Gamma.-undecalactone, 1-(2,3,8,8-Tetramethyl-1,2,3,4,5,6,7,8-octahydronaphthalen-2-Yl)ethanone, 2-(2-(4-Methylcyclohex-3-en-1-Yl)propyl)cyclopentan-1-one, 2-Tert-butylcyclohexyl acetate, 3-Hexenyl salicylate, cis-, 4-(P-hydroxyphenyl)-2-butanone, Bornyl acetate, (-)-, Carbomer interpolymer type A (allyl sucrose crosslinked), Diethyl malonate, Ethyl linalool, Ethyl maltol, Hexahydro-4,7-methanoinden-6-yl propionate, Hexyl acetate, Hexyl salicylate, Polyoxyl 40 hydrogenated castor oil, Propylene glycol, Trolamine, Water

Kleen Hand Sanitizer Mango Label 90mLKleen Hand Sanitizer Mango Label 100mLKleen Hand Sanitizer Mango 250 ml LabelKleen Hand Sanitizer Mango 320ml LabelKleen Hand Sanitizer Mango 500ml Label

KLEEN HAND SANITIZER MANGO 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79741-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIETHYL MALONATE (UNII: 53A58PA183)  
BORNYL ACETATE, (-)- (UNII: 24QAP1VCUX)  
HEXYL ACETATE (UNII: 7U7KU3MWT0)  
2-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 364FV60913)  
ETHYL LINALOOL (UNII: SF2JS9GF5T)  
ETHYL MALTOL (UNII: L6Q8K29L05)  
HEXAHYDRO-4,7-METHANOINDEN-6-YL PROPIONATE (UNII: S3ASM14UAS)  
4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
2-(2-(4-METHYLCYCLOHEX-3-EN-1-YL)PROPYL)CYCLOPENTAN-1-ONE (UNII: P1K3Z8A8HJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
HEXYL SALICYLATE (UNII: 8F78EY72YL)  
1-(2,3,8,8-TETRAMETHYL-1,2,3,4,5,6,7,8-OCTAHYDRONAPHTHALEN-2-YL)ETHANONE (UNII: 1GD7ODM28Y)  
TROLAMINE (UNII: 9O3K93S3TK)  
.GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)  
WATER (UNII: 059QF0KO0R)  
3-HEXENYL SALICYLATE, CIS- (UNII: C78Y9OR6YH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79741-003-0990 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2020
2NDC:79741-003-10100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2020
3NDC:79741-003-25250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/15/2020
4NDC:79741-003-32320 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/15/2020
5NDC:79741-003-50500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/15/2020
Labeler - SAIGON COSMETICS CORPORATION (555265180)
Registrant - SAIGON COSMETICS CORPORATION (555265180)
Establishment
NameAddressID/FEIBusiness Operations
SAIGON COSMETICS CORPORATION555265180manufacture(79741-003)

Revised: 8/2020
Document Id: ad64279b-3377-8698-e053-2a95a90ab898
Set id: ad64279b-3376-8698-e053-2a95a90ab898
Version: 1
Effective Time: 20200821
 
SAIGON COSMETICS CORPORATION