71883-003_Dr. Oracle OH MY CLEAN Hand Sanitizer

Dr. Oracle OH MY CLEAN Hand Sanitizer by

Drug Labeling and Warnings

Dr. Oracle OH MY CLEAN Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Oracle Cosmetic Co., Ltd., SISKINKOREA CO.,LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DR. ORACLE OH MY CLEAN HAND SANITIZER- alcohol gel 
Oracle Cosmetic 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.

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71883-003_Dr. Oracle OH MY CLEAN Hand Sanitizer

03 500 70

DR. ORACLE OH MY CLEAN HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71883-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)  
WATER (UNII: 059QF0KO0R)  
ROSEMARY (UNII: IJ67X351P9)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71883-003-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/20/202004/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/20/202004/30/2023
Labeler - Oracle Cosmetic Co., Ltd. (688258270)
Registrant - Oracle Cosmetic Co., Ltd. (688258270)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory301029984manufacture(71883-003)

Revised: 5/2023
Document Id: fc9db41a-9c5c-9ab6-e053-6394a90abe07
Set id: 2df801d7-08ed-426e-be88-94e49a010439
Version: 2
Effective Time: 20230526