ADVANCED- ethyl alcohol gel 
MFG Chemical, LLC.

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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Active Ingredient Purpose

Ethyl Alcohol 80% v/v............................................................................................................................................................. Antimicrobial

Hand Sanitizer to help reduce bacteria on the skin.

Flammable. Keep away from heat or flame.

For external use only.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Store below 110 oF (43 oC)

May discolor certain fabrics or surfaces

Water (Aqua), Tert-butanol, Polyacrylate, Aminomethyl Propanol

For external use only

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Hand Sanitizer to help reduce bacteria on the skin.

Advanced Hand Sanitizer Label

ADVANCED 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77809-070
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) 29.23 mL  in 100 mL
TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.125 mL  in 100 mL
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U) 0.4 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.25 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77809-070-017560 mL in 1 JUG; Type 0: Not a Combination Product09/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/25/2020
Labeler - MFG Chemical, LLC. (066924424)
Registrant - MFG Chemical, LLC. (066924424)
Establishment
NameAddressID/FEIBusiness Operations
MFG Chemical, LLC.789380354manufacture(77809-070)

Revised: 9/2020
Document Id: af854c92-1326-f608-e053-2a95a90ae8f6
Set id: af854c92-1325-f608-e053-2a95a90ae8f6
Version: 1
Effective Time: 20200917
 
MFG Chemical, LLC.