BERNAL PREMIUM HAND SANITIZER- alcohol gel

Bernal Premium Hand Sanitizer by

Drug Labeling and Warnings

Bernal Premium Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Inflatables LLC, LABORATORIOS BREMER, S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

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 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.

STOP USE

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.

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 ingredients

Carbomer, Triethanolamine, Water

Package Label - Principal Display Panel

30 mL NDC: 74541-370-01

INGREDIENTS AND APPEARANCE

BERNAL PREMIUM HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74541-370
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
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74541-370-01	30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/30/2020
2	NDC: 74541-370-02	60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/30/2020
3	NDC: 74541-370-04	130 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/30/2020
4	NDC: 74541-370-08	220 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/30/2020
5	NDC: 74541-370-10	300 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/30/2020
6	NDC: 74541-370-17	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/30/2020
7	NDC: 74541-370-34	1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/30/2020
8	NDC: 74541-370-37	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Inflatables LLC (108619168)

Registrant - LABORATORIOS BREMER, S.A. (811585264)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATORIOS BREMER, S.A.		811585264	manufacture(74541-370)