BAROLON HAND SANITIZER- ethyl alcohol gel 
Barolon Labs

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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Barolon HAND SANITIZER

Drug Facts

Active Ingredients

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Use:

Hand sanitizer to help reduce bacteria on skin.

Warnings:

Flammable. Keep away from fire or flame.
For external use only.
When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions:

Put enough product in your palm to cover hands and rub hands together briskly until dry.
Children under 6 years of age should be supervised when using.

Other information:

Store below 110°F (43°C)

Inactive ingredients:

Water (Aqua), Aloe Barbadensis Leaf Juice, Isopropyl Alcohol, Caprylyl Glycol, Glycerin, Isopropyl Myristate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Tocopherol Acetate.

MADE WITH PLANT EXTRACTS AND SKIN CONDITIONERS

HIGH POTENCY 70% ALCOHOL FORMULA

Dist By: BAROLON INC. SOUTH HOLLAND, IL 60473

Packaging

image description

BAROLON HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76723-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76723-100-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2020
2NDC:76723-100-283785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/23/2020
Labeler - Barolon Labs (099833566)

Revised: 5/2020
Document Id: 30fb8e6a-0b62-4a29-8291-e9b9166a6184
Set id: bd6d0f5a-fec6-43e7-8863-02d774302dfd
Version: 2
Effective Time: 20200530
 
Barolon Labs