IBARRA by PROMAQUILA DE COCULA, S.A. DE C.V. IBARRA- alcohol gel

IBARRA by

Drug Labeling and Warnings

IBARRA by is a Otc medication manufactured, distributed, or labeled by PROMAQUILA DE COCULA, S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

Active ingredient. Ethyl Alcohol 70%

PURPOSE

Purpose Antmicrobial

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.

Directions

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

DOSAGE AND ADMINISTRATION

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

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

STOP USE SECTION

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

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.

INCTIVE INGREDIENTS

Inactive ingredients Water, Glycerin, Carbomer, Triethanolamine, Aloe Vera Leaf, Menthol

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

IBARRA 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79577-0003
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)	0.28511 mL  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.00302 mL  in 1 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.00279 mL  in 1 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.00278 mL  in 1 mL
MENTHOL (UNII: L7T10EIP3A)	0.002 mL  in 1 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.0043 mL  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79577-0003-3	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/04/2020
2	NDC: 79577-0003-4	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/04/2020
3	NDC: 79577-0003-5	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/04/2020

Labeler - PROMAQUILA DE COCULA, S.A. DE C.V. (812760470)

Registrant - PROMAQUILA DE COCULA, S.A. DE C.V. (812760470)

Establishment
Name	Address	ID/FEI	Business Operations
PROMAQUILA DE COCULA, S.A. DE C.V.		812760470	manufacture(79577-0003)