HAND SANITIZER GEL- alcohol solution 
Hill & Markes, 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.

----------

Hand Sanitizer Gel

Moisturizing with Aloe

Effective at eliminating more than 99.9% of many common harmful germs & bacteria in as little as 15 seconds.

Active Ingredient(s)

Ethyl alcohol 70% v/v Purpose Antimicrobial

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin that could cause disease Recommended for repeated use.

Warnings

Flammable. Keep away from fire or flame.

For external use only

Do not use

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

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 in your palm to thoroughly cover your hands Rub hands together briskly until dry

No rinsing required

No towels needed

Other information

Do not store above 110°F (43°C) May discolor certain fabrics or surfaces.

Inactive ingredients

Water (Aqua), Aloe Vera, Propylene Glycol, Carboxethyl Acrylate Crosspolymer, Fragrance, FD&C Blue #1, FD&C Yellow #5

Package Label - Principal Display Panel

24OZ709.76 mL NDC: 78046-1124-1

HAND SANITIZER GEL 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78046-1124
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)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HEPTANAL (UNII: 92N104S3HF)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78046-1124-1709.76 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/19/2020
Labeler - Hill & Markes, Inc. (013616594)

Revised: 5/2020
Document Id: a605e945-851a-0ed1-e053-2995a90ab47c
Set id: a6068f43-c38f-5084-e053-2a95a90a77c1
Version: 1
Effective Time: 20200519
 
Hill & Markes, Inc.