ORBEL- ethyl alcohol liquid 
Bath Concept Cosmetics (Dongguan) 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.

----------

Orbel

Active Ingredient

Ethyl Alcohol-72%

Purpose

Antiseptic Hand Rub

Uses

Hand sanitizer to decrease bacteria on the skin that potentially can cause disease. Recommended for repeated use.

Warnings

For external use only

Avoid contact with eyes.

In case of eye contact, rinse eyes thoroughly with water. Discontinue use if irritation and redness  develop.

Consult a doctor if condition persists for more than 72 hours.

Keep out of reach of children unless under adult supervision.

If swallowed, immediately call Poison Control Center or doctor.

Directions

Questions or Comments ? :

Call +44 (0) 7970 443778

Hours M-F 9am-4pm (GMT)

Other Information

Inactive ingredients

DI water, Glycerin, Methylglucamine, Hydroxyethylcellulose, Fragrance

Principal Display Panel

Orbel

Ethyl Alcohol 72%

Orbel front

Orbel back

ORBEL 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61805-090
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEGLUMINE (UNII: 6HG8UB2MUY)  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-AMYLCINNAMYL ALCOHOL (UNII: DKB52S61GU)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BENZYL BENZOATE (UNII: N863NB338G)  
CITRAL (UNII: T7EU0O9VPP)  
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
COUMARIN (UNII: A4VZ22K1WT)  
EUGENOL (UNII: 3T8H1794QW)  
GERANIOL (UNII: L837108USY)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EVERNIA PRUNASTRI (UNII: O3034Q5AHK)  
PSEUDEVERNIA FURFURACEA (UNII: 49ZMN09Q0K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61805-090-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A05/08/2019
Labeler - Bath Concept Cosmetics (Dongguan) Co., Ltd (529623933)
Registrant - Bath Concept Cosmetics (Dongguan) Co., Ltd (529623933)
Establishment
NameAddressID/FEIBusiness Operations
Bath Concept Cosmetics (Dongguan) Co., Ltd529623933manufacture(61805-090)

Revised: 5/2019
Document Id: c88779b5-adf7-4dd4-a7ed-e735e1469302
Set id: 43115ab2-7d24-44d5-b29f-f73eb0251cc0
Version: 1
Effective Time: 20190508
 
Bath Concept Cosmetics (Dongguan) Co., Ltd