B Clean - Hand Sanitizer 52g

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]

B CLEAN HAND SANITIZER- ethyl alcohol gel 
HETH LLC

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 52g

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 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

Net wt. 7.78 oz (220g)

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

MADE IN BRAZIL

B CLEAN HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78310-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	36.4 g  in 52 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.26 g  in 52 g
MENTHA PIPERITA (UNII: 79M2M2UDA9)	0.0052 g  in 52 g
ISOPROPANOLAMINE (UNII: UE40BY1BZW)	0.053 g  in 52 g
VERBENA OFFICINALIS LEAF (UNII: 3289NQE84P)	0.0052 g  in 52 g
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)	0.0001 g  in 52 g
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	0.26 g  in 52 g
SAGE (UNII: 065C5D077J)	0.0052 g  in 52 g
WATER (UNII: 059QF0KO0R)	15.0113 g  in 52 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78310-103-01	52 g in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/12/2020	06/13/2020

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(78310-103)

Revised: 7/2020

Document Id: aba99580-772b-3d29-e053-2995a90a8156

34390-5

Set id: a7d392ba-c93b-4cf9-e053-2995a90a59f1

Version: 2

Effective Time: 20200730