HAND SANITIZER- ethyl alcohol gel 
B Holding Group LLC

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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Active Ingredient
Ethyl Alcohol 62%

Purpose
Antiseptic

Uses

For hand washing to decrease bacteria on the skin.

Recommended for repeated use.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or rash develops, or if condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help.

Directions

Not recommended for infants.

Wet hands thoroughly with product and allow to dry without wiping.

Children under 6 years of age should be supervised when using this product.

Other Information

Store below 110°F. May cause discoloration to some 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:78396-002
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:78396-002-0159 mL in 1 BOTTLE; 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 - B Holding Group LLC (006108561)

Revised: 5/2020
Document Id: a6bf5d67-d875-77e9-e053-2a95a90a4402
Set id: a6bf75f4-0ce1-8390-e053-2995a90a4488
Version: 1
Effective Time: 20200528
 
B Holding Group LLC