MASCON MEDICAL HAND SANITIZING- alcohol gel

Mascon Medical by

Drug Labeling and Warnings

Mascon Medical by is a Otc medication manufactured, distributed, or labeled by Mascon, Inc., SBC International Group Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredient(s)

Ethyl Alcohol 70%

Purpose

Antimicrobial

Use(s)

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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

When using this product​keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Stop use or ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

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 product to avoid swallowing.

Other Information

• Store between 15-30°C (59-86°F).
• Avoid freezing and excessive heat above 40°C (104°F).

INACTIVE INGREDIENT

Inactive Ingredients Water (Aqua), Isopropyl Alcohol, Carbomer, Triethanolamine, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Fragrance.

PRINCIPAL DISPLAY PANEL

Mascon Medical

Hand Sanitizing Gel

1 Gallon

NDC: 78593-200-00

INGREDIENTS AND APPEARANCE

MASCON MEDICAL  HAND SANITIZING
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78593-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78593-200-00	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/10/2020

Labeler - Mascon, Inc. (106772338)

Establishment
Name	Address	ID/FEI	Business Operations
SBC International Group Inc.		117520462	manufacture(78593-200)