HAND SANITIZER- alcohol gel
Plásticos las Palmas, S.A. de C.V.

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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HAND SANITIZER GEL, AMDAY, BYE VIRUS

DIRECTIONS

PUT ENOUGH PRODUCT IN YOUR PALM TO COVER HANDS AND RUB HANDS TOGETHER BRISKLY UNTIL DRY.

INACTIVE INGREDIENTS

WATER, GLYCERIN, CARBOMER, TRIETHANOLAMINE

DIRECTIONS

PUT ENOUGH PRODUCT IN YOU PALM TO COVER HANDS AND RUB HANDS TOGETHER BRISKLY UNTIL DRY.

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

PURPOSE

ANTIMICROBIAL

WARNINGS

FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

WHEN USING THIS PRODUCT DO NOT USE IN OR NEAR THE EYES.

IN CASE OF CONTACT, FLUSH THORUOUGHLY WITH WATER.

STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH APPEARS OR LASTS.

ACTIVE INGREDIENT

ETHYL ALCOHOL

WARNINGS

FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME

FOR EXTERNAL USE ONLY

HAND SANITIZER GEL

LABEL 250 mL BYE VIRUS LABEL 500 mL BYE VIRUS LABEL 1000 mL BYE VIRUS LABEL 19000 mL BYE VIRUS LABEL 500 mL AMDAY LABEL

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76560-0001
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	0.0375 mL in 1 mL
CARBOMER 980 (UNII: 4Q93RCW27E)	0.002 mL in 1 mL
TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253)	0.002 mL in 1 mL

Product Characteristics
Color	Score	score with uneven pieces
Shape	Size
Flavor	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76560-0001-5	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/07/2020
2	NDC:76560-0001-3	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/07/2020
3	NDC:76560-0001-4	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/07/2020
4	NDC:76560-0001-2	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/07/2020
5	NDC:76560-0001-6	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/07/2020
6	NDC:76560-0001-8	19000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/07/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/07/2020

Labeler - Plásticos las Palmas, S.A. de C.V. (589192967)

Registrant - Plásticos las Palmas, S.A. de C.V. (589192967)

Name	Address	ID/FEI	Business Operations
Establishment
Plásticos las Palmas, S.A. de C.V.		589192967	manufacture(76560-0001)