HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by GRUPO PIRRETEAM SA DE CV, KUII PRODUCTOS DE LIMPIEZA SA DE CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Uses

Uses

* Helps eliminated bacterias on hand. This product is not a substitute of soap hand washing. Avoid contact with broken and damaged skin

Active Ingredient

Active Ingredient Purpose

• Ethyl Alcohol 70%...................................Antiseptic

Warnings

• For external use only
• When using this product avoid contact with eyes. In case of contact, flush with water for several minutes.
• Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.
• Stop use and ask Doctor: if skin irritation develops when using this product
• Flammable: Keep away from heat and flame. Highly flammable liquid and vapor/

Stop use and ask a doctor if

Stop use and ask a doctor if

* Irritation develops while using this product

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

Directions: Place enough product in your palm to throughly cover your hands.

• Rubs hands together briskly until dry
• Children under 6 years of age should be supervised when using this product

Inactive Ingredients

isopropyl alcohol, water, carbomer, benzalkonium chloride

Questions?

QUESTIONS OR COMMENTS: Phone: (786) 599-2764. 24 hours a day, 7 days a week

Uses

Uses

* Helps eliminated bacteria on hand. This product is not a substitute of soap hand washing. Avoid contact with broken and damaged skin

Hand Sanitizer Gel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78797-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78797-002-01	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/09/2020

Labeler - GRUPO PIRRETEAM SA DE CV (951579014)

Registrant - GRUPO PIRRETEAM SA DE CV (951579014)

Establishment
Name	Address	ID/FEI	Business Operations
GRUPO PIRRETEAM SA DE CV		817531659	label(78797-002)

Establishment
Name	Address	ID/FEI	Business Operations
KUII PRODUCTOS DE LIMPIEZA SA DE CV		951578840	manufacture(78797-002)