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NDC 50518-0306-11 HAND SANITIZER 70 mL/100mL Details

HAND SANITIZER 70 mL/100mL

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	50518-0306
Product ID	50518-306_db64ec64-1443-4d99-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	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 50518-0306-11 (50518030611)

Pricing Information	N/A
NDC Package Code	50518-306-11
Billing NDC	50518030611
Package	240 mL in 1 BOTTLE (50518-306-11)
Marketing Start Date	2020-05-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7bdbd149-660c-4a1f-a38e-ac3cf9a35d56 Details

ACTIVE INGREDIENT

ETHYL ALCOHOL 70%

PURPOSE

ANTIMICROBIAL

USES

FOR HANDWASHING TO DECREASE MICROBIAL CONTAMINATION ON THE SKIN
MAY BE REAPPLIED DURING THE DAY AS REQUIRED

WARNINGS

FOR EXTERNAL USE ONLY. DO NOT DRINK.

FLAMMABLE, KEEP AWAY FROM FIRE AND FLAME.

DO NOT USE IN THE EYES. IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER, THEN CONTACT PHYSICIAN.

STOP USE AND ASK A DOCTOR IF IRRITATION AND REDNESS DEVELOP AND 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
BRISKLY RUB HANDS TOGETHER UNTIL DRY
SUPERVISE CHILDREN UNDER 6 YEARS IN THE USE OF PRODUCT

OTHER INFORMATION

STORE AT 20°C TO 25°C (68°F TO 77°F)

MAY DISCOLOR SOME FABRICS

INACTIVE INGREDIENTS

PURIFIED WATER/AQUA/EAU PURIFIE, GLYCERIN, CELLULOSE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 70 PERCENT

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50518-306
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)
GLYCERIN (UNII: PDC6A3C0OX)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50518-306-11	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2020
2	NDC:50518-306-12	480 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(50518-306)

Revised: 3/2022

Document Id: db64ec64-1443-4d99-e053-2a95a90add54

Set id: 7bdbd149-660c-4a1f-a38e-ac3cf9a35d56

Version: 6

Effective Time: 20220329