BE CLEAN ANTISEPTIC HAND GEL- ethyl alcohol gel

BE CLEAN ANTISEPTIC HAND Gel by

Drug Labeling and Warnings

BE CLEAN ANTISEPTIC HAND Gel by is a Otc medication manufactured, distributed, or labeled by Maria Nila Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENT

Ethyl Alcohol 77% v/v

PURPOSE:

Antiseptic

INDICATIONS & USAGE

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

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. 

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

BE CLEAN ANTISEPTIC HAND GEL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79972-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	77 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79972-003-10	300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/10/2020

Labeler - Maria Nila Inc. (117067705)