PROGUARD HAND SANITIZER GEL- ethyl alcohol gel
Gingi-Pak, a division of Belport Co.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ProGuard Hand Sanitizer Gel, 70%

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

ProGuard Hand Sanitizer Gel 10129-081-02

Single Use outer

Single Use inner

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)