B Clean - Hand Sanitizer 440g

B CLEAN HAND SANITIZER by

Drug Labeling and Warnings

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

Drug Details [pdf]

B CLEAN HAND SANITIZER- ethyl alcohol gel 
AGE DO BRASIL INDUSTRIA E COMERCIO LTDA.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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B Clean - Hand Sanitizer 440g

Active Ingredient

Ethyl Alcohol 70% w/w. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Health care personnel hand rub 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 aks 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 certains 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

HAND SANITIZER
ALCOHOL-BASED GEL
moisturizing
Net wt. 15.52 oz (440g)

Manufactured by: Age do
Brasil Ind. e Com. LTDA.
Vinhedo SP
CEP 13288-169
Brazil

Distributed by: Heth LLC
1390 Brickell Ave
Miami FL 33131
+1 844 989 311
MADE IN BRAZIL

Warning! Flammable liquid and vapor

B CLEAN HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78069-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	308 g  in 440 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	127.01876 g  in 440 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	2.2 g  in 440 g
ISOPROPANOLAMINE (UNII: UE40BY1BZW)	0.4488 g  in 440 g
VERBENA OFFICINALIS LEAF (UNII: 3289NQE84P)	0.044 g  in 440 g
SAGE (UNII: 065C5D077J)	0.044 g  in 440 g
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)	0.00044 g  in 440 g
MENTHA PIPERITA (UNII: 79M2M2UDA9)	0.044 g  in 440 g
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	2.2 g  in 440 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78069-001-01	440 g in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2020	06/01/2020
2	NDC: 78069-001-02	440 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/30/2020	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/30/2020	06/01/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
AGE DO BRASIL INDUSTRIA E COMERCIO LTDA.		920307841	manufacture(78069-001)

Revised: 7/2020

Document Id: abae57f7-65c7-12b0-e053-2a95a90afbe8

34390-5

Set id: a60cc7ad-db50-9b5f-e053-2a95a90af02b

Version: 6

Effective Time: 20200730