71883-004_Dr. Oracle PURE HANDS HAND GEL

Dr. Oracle PURE HANDS HAND gel by

Drug Labeling and Warnings

Dr. Oracle PURE HANDS HAND gel by is a Otc medication manufactured, distributed, or labeled by Oracle Cosmetic Co., Ltd., MEGACOS MANUFACTURING Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DR. ORACLE PURE HANDS HAND GEL- 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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71883-004_Dr. Oracle PURE HANDS HAND GEL

03 500 70

DR. ORACLE PURE HANDS HAND GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71883-004
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
WATER (UNII: 059QF0KO0R)  
ALLANTOIN (UNII: 344S277G0Z)  
PANTHENOL (UNII: WV9CM0O67Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71883-004-01300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/03/202012/31/2022
2NDC: 71883-004-02500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/03/202012/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/03/202012/31/2022
Labeler - Oracle Cosmetic Co., Ltd. (688258270)
Registrant - Oracle Cosmetic Co., Ltd. (688258270)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory 689512611manufacture(71883-004)

Revised: 5/2023
Document Id: fc9db479-7718-9b4f-e053-6294a90a0b8a
Set id: 09abab16-b6a0-403a-847b-b16002a7bada
Version: 3
Effective Time: 20230526