BAK-OFF HAND SANITIZER  70 PERCENT- ethyl alcohol gel 
CUSTOM RESEARCH LABS 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.

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CRL (as CMO) - BAK-OFF HAND SANITIZER - 70% ETHYL ALCOHOL (50518-305)

ACTIVE INGREDIENT

ETHYL ALCOHOL 70%

PURPOSE

ANTISEPTIC

USES

TO DECREASE BACTERIA ON THE SKIN

RECOMMENDED FOR REPEATED USE

WARNINGS

FOR EXTERNAL USE ONLY (HANDS).

FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING

OTHER INFORMATION

DO NOT STORE ABOVE 105°F

INACTIVE INGREDIENTS

WATER, ALOE BARBADENSIS LEAF JUICE, GLYCERIN, ISOPROPYL MYRISTATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, PELARGONIUM GRAVEOLENS (GERANIUM) FLOWER OIL, CARBOMER, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL

01b LBL_Bak Off_100mL

BAK-OFF HAND SANITIZER   70 PERCENT
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50518-305
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50518-305-11100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/25/2020
Labeler - CUSTOM RESEARCH LABS INC (028611598)
Registrant - CUSTOM RESEARCH LABS INC (028611598)
Establishment
NameAddressID/FEIBusiness Operations
CUSTOM RESEARCH LABS INC028611598manufacture(50518-305)

Revised: 3/2022
Document Id: db64ec64-1438-4d99-e053-2a95a90add54
Set id: da0c4500-f927-43c4-aa45-fe82a15674f1
Version: 4
Effective Time: 20220329
 
CUSTOM RESEARCH LABS INC