B CLEAN HAND SANITIZER- ethyl alcohol gel

B CLEAN HAND SANITIZER by

Drug Labeling and Warnings

B CLEAN HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by HETH LLC, AGE DO BRASIL INDUSTRIA E COMERCIO LTDA.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

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 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 59º-86ºF (15º-30ºC)
• Avoid freezing and excessive heat above 104ºF (40ºC)
• May discolor certain fabrics

Inactive Ingredients

Aqua, Carbomer, Denatonium Benzoate, Isopropanolamine, Mentha Piperita Extract, Propylene Glycol, Salvia Officinalis Leaf Extract, Verbena Officinalis Leaf Extract

Package Label - Principal Display Panel

B CLEAN

HAND SANITIZER

ALCOHOL-BASED GEL

moisturizing

alcohol 75%

Distributed by: Heth LLC
7522 Campbell Road
Suite 113 #272
Dallas TX 75248
+1 844 989 3111

MADE IN BRAZIL

INGREDIENTS AND APPEARANCE

B CLEAN HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78310-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	60 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
ISOPROPANOLAMINE (UNII: UE40BY1BZW)
VERBENA OFFICINALIS LEAF (UNII: 3289NQE84P)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
SAGE (UNII: 065C5D077J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78310-300-01	4.4 kg in 1 BOTTLE; Type 0: Not a Combination Product	08/07/2020
2	NDC: 78310-300-02	3.32 kg in 1 BOTTLE; Type 0: Not a Combination Product	08/07/2020
3	NDC: 78310-300-03	1.66 kg in 1 BOTTLE; Type 0: Not a Combination Product	08/07/2020
4	NDC: 78310-300-05	0.44 kg in 1 BOTTLE; Type 0: Not a Combination Product	08/07/2020
5	NDC: 78310-300-04	0.865 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/07/2020
6	NDC: 78310-300-06	0.22 kg in 1 BOTTLE; Type 0: Not a Combination Product	08/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/07/2020

Labeler - HETH LLC (080815601)

Registrant - AGE DO BRASIL INDUSTRIA E COMERCIO LTDA. (920307841)

Establishment
Name	Address	ID/FEI	Business Operations
AGE DO BRASIL INDUSTRIA E COMERCIO LTDA.		920307841	manufacture(78310-300)