DR. SAM PREMIUM HAND SANITIZER (500ML)- ethyl alcohol gel 
G.E.O MARKETING CORP

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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Dr. Sam Premium Hand Sanitizer (500mL)

Active ingedient

Ethanol (ethyl alcohol) (62%)

Purpose

Antibacterial

Uses

Hand sanitizer for decreasing bacteria on skin

Warnings

For external use only

Do not use if you are allergic to any of the ingredients

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. avoid contact with broken, irritated, or itching skin. Do not puncture or incinerate.

Stop use and ask a doctor if irritation or redness develops and condition persists for more than 72 hours.

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Apply the adequate amount on hands

Inactive ingredients

Purified water, Glycerin, L-menthol, Carbomer, Aminomethyl Propanol, Aloe extract

Dr. Sam Premium Hand Sanitizer (500mL)

draft dr sam 500

DR. SAM PREMIUM HAND SANITIZER (500ML) 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78012-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ALOE (UNII: V5VD430YW9)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78012-101-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/25/2020
Labeler - G.E.O MARKETING CORP (080740733)
Establishment
NameAddressID/FEIBusiness Operations
Korea Medicare Co.,Ltd.695832135manufacture(78012-101)

Revised: 6/2020
Document Id: a7223fec-8790-46ee-e053-2a95a90ab66f
Set id: a7223fec-878f-46ee-e053-2a95a90ab66f
Version: 1
Effective Time: 20200602
 
G.E.O MARKETING CORP