PPE BUDDY- ethyl alcohol gel

PPE BUDDY by

Drug Labeling and Warnings

PPE BUDDY by is a Otc medication manufactured, distributed, or labeled by Tecnología en Sachets, S.A. de C.V., Gm Integraciones y Soluciones en Control, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active lngredient

Ethyl alcohol 70%

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from heat or flame

For external use only.

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

Stop use and ask a doctor if irritation or rash appears & last.

KEEP OUT OF REACH OF CHILDREN

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 (59-86F)

Avoid freezing and excessive heat above 40°C (104F)

Inactive ingredients

Glycerin, water (Aqua), Triethanolamine, carbomer

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PPE BUDDY 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80014-001
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80014-001-01	2 mL in 1 PACKET; Type 0: Not a Combination Product	08/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/14/2020

Labeler - Tecnología en Sachets, S.A. de C.V. (951580550)

Establishment
Name	Address	ID/FEI	Business Operations
Gm Integraciones y Soluciones en Control, S.A. de C.V.		812758685	manufacture(80014-001)

Establishment
Name	Address	ID/FEI	Business Operations
Tecnología en Sachets, S.A. de C.V.		951580550	repack(80014-001)