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NDC 50518-0305-11 BAK-OFF HAND SANITIZER 70 mL/100mL Details

BAK-OFF HAND SANITIZER 70 mL/100mL

BAK-OFF HAND SANITIZER is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by CUSTOM RESEARCH LABS INC. The primary component is ALCOHOL.

Product Information

NDC	50518-0305
Product ID	50518-305_db64ec64-1438-4d99-e053-2a95a90add54
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	BAK-OFF HAND SANITIZER
Proprietary Name Suffix	70 PERCENT
Non-Proprietary Name	ETHYL ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	CUSTOM RESEARCH LABS INC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 50518-0305-11 (50518030511)

Pricing Information	N/A
NDC Package Code	50518-305-11
Billing NDC	50518030511
Package	100 mL in 1 BOTTLE (50518-305-11)
Marketing Start Date	2020-05-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL da0c4500-f927-43c4-aa45-fe82a15674f1 Details

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

SPL UNCLASSIFIED SECTION

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50518-305-11	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2020

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

Labeler - CUSTOM RESEARCH LABS INC (028611598)

Registrant - CUSTOM RESEARCH LABS INC (028611598)

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

Revised: 3/2022

Document Id: db64ec64-1438-4d99-e053-2a95a90add54

Set id: da0c4500-f927-43c4-aa45-fe82a15674f1

Version: 4

Effective Time: 20220329