PROGUARD HAND SANITIZER GEL- ethyl alcohol gel

ProGuard Hand Sanitizer Gel by

Drug Labeling and Warnings

ProGuard Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Gingi-Pak, a division of Belport Co., Jeff Nichols. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/26/2020

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

Registrant - Jeff Nichols (008480121)

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