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NDC 10129-0080-02 iBrite Hand Sanitizer 70 mL/100mL Details

iBrite Hand Sanitizer 70 mL/100mL

iBrite Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Gingi-Pak. The primary component is ALCOHOL.

Product Information

NDC	10129-0080
Product ID	10129-080_a21744dd-b5f7-0594-e053-2a95a90a19fb
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	iBrite Hand Sanitizer
Proprietary Name Suffix	n/a
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	Gingi-Pak
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 10129-0080-02 (10129008002)

Pricing Information	N/A
NDC Package Code	10129-080-02
Billing NDC	10129008002
Package	472 mL in 1 BOTTLE, DISPENSING (10129-080-02)
Marketing Start Date	2020-04-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a21745b5-c65b-05ce-e053-2a95a90acfc2 Details

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Reduce bacteria that potentially can cause disease.

Recommened for repeated use

Warnings

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

Do not use

Do not apply around eyes.

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 or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Dispense enough gel in your palm to cover all surfaces of hands and finger. Rub hands together vigorously until dry.
Usage on children requires adult supervision, not recommended for infants.
Work best on clean and dry hands.

Other information

Store below 43 C (110F)
May discolor certain fabrics or surfaces

Inactive ingredients

Distilled Water, Glycerin, Carbomer 940, Benzophenone-4, Aloe Vera, Aminomethyl Propanol.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

IBRITE HAND SANITIZER

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-080
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
SULISOBENZONE (UNII: 1W6L629B4K)	0.05 g in 100 mL
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)	0.32 g in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.5 mL in 100 mL
WATER (UNII: 059QF0KO0R)	29 mL in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.16 g in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10129-080-01	59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/10/2020
2	NDC:10129-080-02	472 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/10/2020
3	NDC:10129-080-03	250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/10/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/10/2020

Labeler - Gingi-Pak (008480121)

Revised: 4/2020

Document Id: a21744dd-b5f7-0594-e053-2a95a90a19fb

Set id: a21745b5-c65b-05ce-e053-2a95a90acfc2

Version: 1

Effective Time: 20200410