PPEBuddy by PPE Buddy LLC PPEBUDDY- alcohol kit

PPEBuddy by

Drug Labeling and Warnings

PPEBuddy by is a Otc medication manufactured, distributed, or labeled by PPE Buddy LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Active Ingredients

Ethyl alcohol 70%

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria on the skin

Warnings

Flammable. Keep away from fire or flame. 

For external use only.

When using this product

do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation or rash appears and lasts. 

Keep out of reach of children.

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

Directions:

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information:

Store between 15-30°C (59-86°F). Avoid freezing and excessive heat above 40°C (104°F).

Inactive Ingredients:

Glycerin, Water (Aqua), Triethanolamine, Carbomer

Drug facts

Active Ingredients

Ethyl alcohol 70%

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria on the skin

Warnings

For external use only.

When using this product

do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation or rash appears and lasts.

Keep out of reach of children.

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

Directions:

This product should be used as a part of the daily cleansing routine.

Wipe hands; allow to dry. Discard.

Inactive Ingredients:

Glycerin, Distilled water, Aroma

Kit Labeling:

Package Labeling:79437-000-00

Package Labeling:79437-003-00

INGREDIENTS AND APPEARANCE

PPEBUDDY 
alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79437-004

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79437-004-00	1 in 1 KIT	07/24/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 PACKET	2 mL
Part 2	1 PATCH	4 mL

Part 1 of 2

PPEBUDDY SINGLE USE HAND SANITIZER S001 
alcohol gel

Product Information
Item Code (Source)	NDC: 79437-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79437-000-00	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	part333E	07/24/2020

Part 2 of 2

PPEBUDDY DISINFECTING WIPE D001 
alcohol cloth

Product Information
Item Code (Source)	NDC: 79437-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79437-003-00	1 in 1 PACKET
1		4 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/24/2020

Labeler - PPE Buddy LLC (117556781)