MANDARIN ORANGE SCENTED ANTISEPTIC HAND SANITIZER 80 ETHYL ALCOHOL- alcohol liquid 
H&Y Products LLC dba Kolonya Carre

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Mandarin Orange Scented Antiseptic Hand Sanitizer Spray 80 % Ethyl Alcohol

Drug Facts

Active ingredient

Ethyl alcohol 80%

Purpose

Antiseptic

Use

for hand washing to decrease bacteria on the skin.

Warnings

For external use onlyFlammable, keep away from fire or flame.

Do not use

  • in the eyes

Stop use and ask a doctor if

  • irritation and redness develop.
  • condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Inactive ingredients

Water, Fragrance, Alpha isomethyl ionone, Benzyl salicylate, Butylphenyl methylpropional, Citral, Citronellol, Coumarin, Limonene, Linalool

Package Labeling:82127-004-01

Outer Package9Inner Package9

Package Labeling:82127-004-02

Outer Package10Inner Package10

MANDARIN ORANGE SCENTED ANTISEPTIC HAND SANITIZER 80 ETHYL ALCOHOL 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82127-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
CITRAL (UNII: T7EU0O9VPP)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
COUMARIN (UNII: A4VZ22K1WT)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82127-004-011 in 1 BOX08/01/202107/31/2025
135 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:82127-004-021 in 1 BOX08/01/202107/31/2025
290 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)08/01/202107/31/2025
Labeler - H&Y Products LLC dba Kolonya Carre (070644433)

Revised: 12/2023
Document Id: 0daab837-6092-b472-e063-6394a90a360f
Set id: eef49bc3-a75c-4168-9cb3-4f533ea2ab45
Version: 3
Effective Time: 20231229
 
H&Y Products LLC dba Kolonya Carre