ESSENTIALS, M.D. HAND SANITIZER- alcohol gel 
ALLEN-MEYER GROUP 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

Ethyl Alcohol 70% v/v.

Purpose

Antimicrobial

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Reccomended for repeated use.

Warnings

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 with eyes, 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.

Directions

Other information

Inactive ingredients

Water, Isopropyl alcohol, Carbomer, Glycerin, Aminomethy Propanol.

Product Label

image description

image description

ESSENTIALS, M.D. HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77205-002
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)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77205-002-011500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
2NDC:77205-002-025000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/30/2020
Labeler - ALLEN-MEYER GROUP LLC (117509579)

Revised: 6/2020
Document Id: bcdfd5a0-4639-4f4d-b0ce-ef253cf82299
Set id: bb95f6c3-2e5e-498c-9f05-535be81ad8c5
Version: 1
Effective Time: 20200630
 
ALLEN-MEYER GROUP LLC