BAK-OFF HAND SANITIZER 70 PERCENT- ethyl alcohol gel

BAK-OFF HAND SANITIZER by

Drug Labeling and Warnings

BAK-OFF HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by CUSTOM RESEARCH LABS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• KEEP OUT OF EYES. IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER.
• AVOID CONTACT WITH BROKEN SKIN
• DO NOT INHALE OR INHEST

STOP USE AND ASK A DOCTOR IF

• IRRITATION AND REDNESS DEVELOP
• CONDITION PERSISTS FOR MORE THAN 72 HOURS

KEEP OUT OF REACH OF CHILDREN

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

• FOR CHILDREN UNDER 6, USE ONLY UNDER ADULT SUPERVISION
• NOT RECOMMENDED FOR INFANTS

OTHER INFORMATION

DO NOT STORE ABOVE 105°F

• MAY DISCOLOR SOME FABRICS
• HARMFUL TO WOOD FINISHES AND PLASTICS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BAK-OFF HAND SANITIZER  70 PERCENT
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50518-305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50518-305-11	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/25/2020

Labeler - CUSTOM RESEARCH LABS INC (028611598)

Registrant - CUSTOM RESEARCH LABS INC (028611598)

Establishment
Name	Address	ID/FEI	Business Operations
CUSTOM RESEARCH LABS INC		028611598	manufacture(50518-305)