ANTIBACTERIAL HAND SANITIZING- alcohol gel 
MaKMaC 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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ANTIBACTERIAL HAND SANITIZING GEL

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use

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

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

Label

ANTIBACTERIAL HAND SANITIZING 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78080-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78080-001-00250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/07/2020
Labeler - MaKMaC Inc (128886705)

Revised: 5/2020
Document Id: a604dbda-edb2-edcd-e053-2a95a90a4794
Set id: 4a98a9f0-9931-4904-8470-b925e32da8e2
Version: 1
Effective Time: 20200519
 
MaKMaC Inc