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NDC 71513-0202-30 Antibacterial Hand Sanitizer 62 mL/100mL Details

Antibacterial Hand Sanitizer 62 mL/100mL

Antibacterial Hand Sanitizer is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Broder Bros Co.. The primary component is ALCOHOL.

Product Information

NDC	71513-0202
Product ID	71513-202_edfe5dbf-1a60-4cd6-e053-2995a90a3521
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	Antibacterial Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	62
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Broder Bros Co.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71513-0202-30 (71513020230)

Pricing Information	N/A
NDC Package Code	71513-202-30
Billing NDC	71513020230
Package	10 mL in 1 BOTTLE (71513-202-30)
Marketing Start Date	2020-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d4b3f6cf-52d3-1755-e053-2a95a90a9482 Details

Drug Facts

Active ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

For hand sanitizing

Warnings

Flammable.Keep away from heat and flame.
For external use only.

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 ingest

Stop use and ask a doctor

if irritation and redness develops and persists for more than 72 hours

Keep out of reach of children

If swallowed get medical help or call a Poison Control Center right away

Directions

Wet hands thoroughly with product, briskly rub together until dry.
Always supervise children in use of this product.
Children under 6 months of age: Ask a doctor.

Other information

Store at 66° to 77° F (22° to 25° C)

Inactive ingredients

Aloe Barbadensis Leaf Extract, Carbomer, Deionizer Water, Fragrance, Glycerin, Propylene Glycol, Tocopherol Acetate, Triethanolamine

Questions?

1-800-873-7746 M-F 8 am - 5 pm EST

SPL UNCLASSIFIED SECTION

Net wt. 10 mL/0.33 fl. oz.

Made in China

Dist. By Broder Bros Co., dba Prime Line

Gaffney, SC 29341

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND SANITIZER

ethyl alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71513-202
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71513-202-30	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020
2	NDC:71513-202-31	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/01/2020

Labeler - Broder Bros Co. (107044246)

Revised: 11/2022

Document Id: edfe5dbf-1a60-4cd6-e053-2995a90a3521

Set id: d4b3f6cf-52d3-1755-e053-2a95a90a9482

Version: 2

Effective Time: 20221121