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NDC 10129-0081-08 ProGuard Hand Sanitizer Gel 70 mL/100mL Details

ProGuard Hand Sanitizer Gel 70 mL/100mL

ProGuard Hand Sanitizer Gel is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Gingi-Pak, a division of Belport Co.. The primary component is ALCOHOL.

Product Information

NDC	10129-0081
Product ID	10129-081_ac8a52ca-20ef-aa77-e053-2995a90a8011
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	ProGuard Hand Sanitizer Gel
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, a division of Belport Co.
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 10129-0081-08 (10129008108)

Pricing Information	N/A
NDC Package Code	10129-081-08
Billing NDC	10129008108
Package	250 mL in 1 BOTTLE, DISPENSING (10129-081-08)
Marketing Start Date	2020-06-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a8ed8f4a-7072-241b-e053-2995a90af9af Details

Active Ingredient

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: hands. Flammable. Keep away from heat or flame.

Do Not Use

around eyes
in children less than 2 month of age
on open skin wounds

When Using This Product

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

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.

Principal Display

INGREDIENTS AND APPEARANCE

PROGUARD HAND SANITIZER GEL

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-081
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
WATER (UNII: 059QF0KO0R)	29 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.16 g in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.5 mL in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	0.32 g in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10129-081-02	59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/26/2020
2	NDC:10129-081-08	250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/26/2020
3	NDC:10129-081-16	472 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/26/2020
4	NDC:10129-081-01	3785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/26/2020
5	NDC:10129-081-07	48 in 1 CARTON	09/18/2020
5		2 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/26/2020

Labeler - Gingi-Pak, a division of Belport Co. (008480121)

Registrant - Jeff Nichols (008480121)

Name	Address	ID/FEI	Business Operations
Establishment
Gingi-Pak, a division of Belport Co.		008480121	manufacture(10129-081)

Revised: 8/2020

Document Id: ac8a52ca-20ef-aa77-e053-2995a90a8011

Set id: a8ed8f4a-7072-241b-e053-2995a90af9af

Version: 3

Effective Time: 20200810