BV BYE VIRUS 99- ethyl alcohol gel

BV BYE VIRUS 99 by

Drug Labeling and Warnings

BV BYE VIRUS 99 by is a Otc medication manufactured, distributed, or labeled by COMERCIAL GOURA,S. DE R.L.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE AND ADMINISTRATION

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Children under 6 years of age should be supervised when using.

WARNINGS AND PRECAUTIONS

Store below 110°F (43°C)

Children under 6 years of age should be supervised when using.

WARNINGS

Warnings

For external use only. Flammable. Keep away from heat or flame

ACTIVE INGREDIENT

Active ingredienT Ethyl Alcohol 70% v/v…

INACTIVE INGREDIENTS

Water (Aqua), Glycerin, Carbomer, Triethanolamine

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

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

PURPOSE

PURPOSE ANTIMICROBIAL

INDICATIONS AND USAGE

Use[s]

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

PACKAGE LABELS

INGREDIENTS AND APPEARANCE

BV BYE VIRUS 99 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78501-4000
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
WATER (UNII: 059QF0KO0R)	0.2585 mL  in 1 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.002 mL  in 1 mL
TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253)	0.002 mL  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.0375 mL  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78501-4000-4	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020
2	NDC: 78501-4000-5	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020
3	NDC: 78501-4000-6	125 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020
4	NDC: 78501-4000-7	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020
5	NDC: 78501-4000-8	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020
6	NDC: 78501-4000-9	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020
7	NDC: 78501-4000-1	19000 mL in 1 PAIL; Type 0: Not a Combination Product	06/29/2020
8	NDC: 78501-4000-2	4000 mL in 1 JUG; Type 0: Not a Combination Product	06/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/29/2020

Labeler - COMERCIAL GOURA,S. DE R.L. (951578628)

Registrant - COMERCIAL GOURA,S. DE R.L. (951578628)

Establishment
Name	Address	ID/FEI	Business Operations
COMERCIAL GOURA,S. DE R.L.		951578628	manufacture(78501-4000)