HAND SANITIZER- ethyl alcohol gel 
SentryPPE, 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.

----------

Active Ingredient
Ethyl Alcohol 62% v/v

Purpose
Antiseptic

Uses:

Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water 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 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 way.

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.

Other Information:

Store between 15-30℃(59-86℉)

Avoid freezing and excessive heat above 40℃(104℉)

May discolor certain fabrics or surfaces.

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Maltodextrin,Glycerin, Propylene Glycol, Acrylates/C1O-30 Alkyl Acrylate Crosspolymer, Triethanoamine, Fragrance, Tocopheryl Acetate.

image of bottle label

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78398-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78398-008-01236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/29/2020
Labeler - SentryPPE, Inc. (117289386)

Revised: 5/2020
Document Id: a6c043ce-83ca-46c8-e053-2995a90a11e5
Set id: a6c009a3-9c74-2769-e053-2995a90a316c
Version: 1
Effective Time: 20200528
 
SentryPPE, Inc.