PPEBUDDY- alcohol 
PPE Buddy LLC

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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PPEBuddy Kit

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:

Kit

Package Labeling:79437-000-00

Label

Package Labeling:79437-003-00

Label4

PPEBUDDY 
alcohol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79437-004
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79437-004-001 in 1 KIT07/24/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 2 mL
Part 21 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79437-000-002 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/24/2020
Part 2 of 2
PPEBUDDY DISINFECTING WIPE D001 
alcohol cloth
Product Information
Item Code (Source)NDC:79437-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79437-003-001 in 1 PACKET
14 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/24/2020
Labeler - PPE Buddy LLC (117556781)

Revised: 8/2020
Document Id: ac358917-d400-0dac-e053-2a95a90a6c2d
Set id: 7240474d-6cfa-4cc8-bccb-94af8fbb3c1c
Version: 2
Effective Time: 20200806
 
PPE Buddy LLC