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NDC 71513-0103-09 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	71513-0103
Product ID	71513-103_d4b4e641-3a56-09ea-e053-2a95a90a034a
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 71513-0103-09 (71513010309)

Pricing Information	N/A
NDC Package Code	71513-103-09
Billing NDC	71513010309
Package	50 mL in 1 BOTTLE (71513-103-09)
Marketing Start Date	2020-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d4b4e641-3a55-09ea-e053-2a95a90a034a Details

Drug Facts

Active ingredient

Alcohol 62%

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on the skin

Warnings

For external use only

Flammable, keep away from fire and flame

When using this product

Avoid the eyes and mucous membranes
In the case of eyes or mucous membranes contact, rinse area thoroughly with water
In case of deep or punture wounds or serious burns, consult physician.
If redness,irritation,swelling, or pain persists or increases or if infection occurs discontinue use and consult physician.

Keep out of reach of children

If swallowed,contact a doctor or Poison Control Center immediately

Directions

Rub dime sized amount between hands until dry.
Supervise children in the use of this product.
In the case of eye contact, rinse eyes thoroughly with water.

Other information

Store below 105 F

Inactive Ingredients

Aminomethyl Propanol, Carbomer, Water.

Questions?

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

SPL UNCLASSIFIED SECTION

hand sanitizer

1.7 FL OZ (50mL)

Batch: PXXXXX PC191

Exp:

Dist. By: Broder Bros. Col,

dba Prime Line

Gaffney, SC 29341

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71513-103
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71513-103-09	50 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: 1/2022

Document Id: d4b4e641-3a56-09ea-e053-2a95a90a034a

Set id: d4b4e641-3a55-09ea-e053-2a95a90a034a

Version: 1

Effective Time: 20220101