JMJ CATALINA- ethyl alcohol gel

JMJ Catalina by

Drug Labeling and Warnings

JMJ Catalina by is a Otc medication manufactured, distributed, or labeled by JMJ CATALINA USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient(s)

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Use(s)

Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Warnings

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

Do not use

In children less than 2 months of age

On open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

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 15-30C (59-86F)

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

INACTIVE INGREDIENT

Inactive Ingredients Water, Carbomer, Aminomethyl propanol, Triethanolamine, Aloe, Fragrance, Glycerin, Propylene glycol, Tocopheryl acetate

SPL UNCLASSIFIED SECTION

Topical Solution

KILLS 99.99% OF GERMS* INCLUDING COVID-19

MADE IN U. S. A.

Peach

Manufactured by: 

JMJ Catalina U. S. A. LLC

Tucson, AZ 85714

Packaging

INGREDIENTS AND APPEARANCE

JMJ CATALINA 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78938-333
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)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE (UNII: V5VD430YW9)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color		Score
Shape		Size
Flavor	PEACH, ORANGE, CITRUS	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78938-333-25	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2020
2	NDC: 78938-333-27	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2020
3	NDC: 78938-333-29	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/11/2020

Labeler - JMJ CATALINA USA LLC (072604132)

Establishment
Name	Address	ID/FEI	Business Operations
JMJ CATALINA USA LLC		072604132	manufacture(78938-333)