BERKLEY JENSEN INSTANT SANITIZER- ethyl alcohol liquid 
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, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE

QUESTIONS OR COMMENTS?

1-800-934-1204

LABEL COPY

IMAGE OF THE LABEL

LABEL COPY

IMAGE OF THE LABEL

BERKLEY JENSEN  INSTANT SANITIZER
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-167
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)  
CARBOMER 934 (UNII: Z135WT9208)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68391-167-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:68391-167-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/13/2015
Labeler - BJWC (159082692)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(68391-167)

Revised: 1/2015
Document Id: a026b5c9-d9e2-4b7d-86bc-f36a0c1ed36f
Set id: bca300d1-06ca-4e4f-a07a-3afa37a4ae4a
Version: 1
Effective Time: 20150114
 
BJWC