BERKLEY JENSEN INSTANT HAND SANITIZER- ethyl alcohol gel 
BJWC

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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Drug Facts

Active ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

to help reduce bacteria on the skin.

Warnings

When using this product

avoid contact with eyes. If contact occurs, rinse with water.

Stop using this product and ask doctor if 

irritation or redness develops and lasts.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

wet hands thoroughly and rub together until dry.

Other information

store at a temperature below 110°F (43°C)

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum).

Questions or comments?

1-800-934-1204

Label Copy 2 fl oz

image of the label 2 oz

Label Copy 12 fl oz

image of the label 12 oz

BERKLEY JENSEN INSTANT HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-168
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL650 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
CARBOMER 934 (UNII: Z135WT9208)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68391-168-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/2020
2NDC:68391-168-08354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/13/2020
Labeler - BJWC (159082692)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care Inc.201901209manufacture(68391-168)

Revised: 3/2020
Document Id: 5265ddb4-5f61-4dd7-ad67-2d4d474270fa
Set id: 7f068b75-409b-4fb1-b455-8358322563ec
Version: 1
Effective Time: 20200316
 
BJWC