ANTIBACTERIAL HAND SANITIZING- alcohol gel

ANTIBACTERIAL HAND SANITIZING by

Drug Labeling and Warnings

ANTIBACTERIAL HAND SANITIZING by is a Otc medication manufactured, distributed, or labeled by MaKMaC Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use

• Antibacterial hand sanitizing gel to help killing bacteria and germs as antiseptic on the skin. For use when soap and water are not available.

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product

keep out of eyes and mouth. In case of contact with eyes, immediately rinse eyes thoroughly with water

Stop use and ask doctor

If irritation, rash or allergy 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

• Apply. Put enough product on hands to cover all surfaces. Rub hands together, until hands feel dry. This should take around 20 seconds.  recommended for repeated use.
•  Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 59-86ºF (15-30ºC) avoid freezing and excessive heat above 104ºF (40ºC)

Inactive ingredients

Deionized Water. Carbomer. Panthenol. D-Limonene. DMDM Hydantoin. Disodium EDTA Triethanolamine.

Package Labeling

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND SANITIZING 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78080-001
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
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PANTHENOL (UNII: WV9CM0O67Z)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78080-001-00	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/07/2020

Labeler - MaKMaC Inc (128886705)