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NDC 71513-0102-08 Hand Sanitizer 0.62 mL/mL Details

Hand Sanitizer 0.62 mL/mL

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

Product Information

NDC	71513-0102
Product ID	71513-102_edfe5dbf-1a5f-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	Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	0.62
Active Ingredient Units	mL/mL
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 71513-0102-08 (71513010208)

Pricing Information	N/A
NDC Package Code	71513-102-08
Billing NDC	71513010208
Package	65 mL in 1 BOTTLE (71513-102-08)
Marketing Start Date	2020-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d4b45a38-4e81-9dcb-e053-2a95a90aa576 Details

Drug Facts

Active ingredient

Alcohol 62%

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on skin

Warnings

Flammable. Keep away from fire and flame.

For external use only

When using this product

Keep out of eyes.
In the case of contact with eyes flush thoroughly with water.
Avoid contact with broken skin.
Do not inhale or ingest.

Stop use & ask 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 contact a Poison Control Center immediately

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 68°F to 77°F (20°C to 25°C).

Inactive Ingredients

Carbopol 940, Fragrance, Triethanolamine, Water.

Questions?

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

SPL UNCLASSIFIED SECTION

Hand Sanitizer

Net. wt. 2.19 Fl. oz. (65mL)

Lot no: Use by:

Made in China

Dist. by: Broder Bros. Co., dba Prime Line

Bridgeport, CT 06610/Gaffney, SC 29341

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71513-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 940 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71513-102-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020
2	NDC:71513-102-08	65 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-1a5f-4cd6-e053-2995a90a3521

Set id: d4b45a38-4e81-9dcb-e053-2a95a90aa576

Version: 2

Effective Time: 20221121