Antiseptic Hand Gel Berry/Muguet Ethyl Alcohol

Antiseptic Hand Gel Berry/Muguet Ethyl Alcohol

Drug Labeling and Warnings

Drug Details

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ANTISEPTIC HAND BERRY MUGUET ETHYL ALCOHOL- alcohol gel 
Hangzhou Hygen Health Bio-technology 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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Antiseptic Hand Gel Berry/Muguet Ethyl Alcohol

Drug Facts

Active Ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Use

  • for handwashing to decrease bacteria on the skin.

Warnings

For external use only

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

  • wet hands thoroughly with product and allow to dry without wiping.

Inactive ingredients

Water, Carbomer, Triethanolamine, Peg-6 Caprylic/Capric Glycerides, Glycerin, Fragrance, Lactose, Sorbitol, Microcrystalline Cellulose, Hydroxypropyl Methyl Cellulose, Jojoba Esters, FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40

Package Labeling:

Label

ANTISEPTIC HAND BERRY MUGUET ETHYL ALCOHOL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73125-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL650 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)  
GLYCERIN (UNII: PDC6A3C0OX)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
SORBITOL (UNII: 506T60A25R)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73125-000-00300 mL in 1 BOTTLE; Type 0: Not a Combination Product07/16/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/16/2019
Labeler - Hangzhou Hygen Health Bio-technology Co. Ltd. (554488997)
Establishment
NameAddressID/FEIBusiness Operations
Hangzhou Hygen Health Bio-technology Co. Ltd.554488997manufacture(73125-000)

Revised: 3/2020
 
Hangzhou Hygen Health Bio-technology Co. Ltd.


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