BE CLEAN ANTISEPTIC HAND GEL- ethyl alcohol gel 
Maria Nila Inc.

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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MARIA NILA BE CLEAN ANTISEPTIC HAND GEL

DRUG FACTS

ACTIVE INGREDIENT

Ethyl Alcohol 77% v/v

PURPOSE:

Antiseptic

USES(S): Hand sanitizer to help reduce bacteria that potentially can cause disease.

WARNINGS: For external use only. Flammable. Keep away from heat or flame. 

DO NOT USE: On children less than 2 months of age. On open skin wounds.

WHEN USING THIS PRODUCT: Keep out of eyes, ears, mouth, or open orifices. Rinse eyes thoroughly with water and contact a physician if needed. Avoid ingestion.

STOP USE AND ASK A DOCTOR: If irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN: If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS: Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing. 

OTHER INFORMATION: Store between 15-25C (59-77F). Avoid freezing and excessive heat.

INACTIVE INGREDIENTS: Water (Aqua), Propylene Glycol, Glycerin, Isopropyl Myristate, Carbomer, Aminomethyl Propanol.

GEL MAINS ANTI-SEPTIQUE

ALCOHOL BASED 77%

100% VEGAN

CRUELTY FREE

HIGH SKIN COMPATIBILITY

CLIMATE COMPENSATED

Made in USA

Distributed by Maria Nila Inc. 900 Third Avenue, 29th Floor, New York, New York 10022

www.marianila.com

Packaging

untitled

BE CLEAN ANTISEPTIC HAND GEL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79972-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL77 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79972-003-10300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/10/2020
Labeler - Maria Nila Inc. (117067705)

Revised: 8/2020
Document Id: 9c7943e1-48f4-4f18-a865-fb5d64e3c647
Set id: 55ddd1a1-883f-4a6b-82b9-e121696317a7
Version: 1
Effective Time: 20200805
 
Maria Nila Inc.