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 (220g, 104g, 52g)

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

Other information

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

NDC 78310-102-03NDC 78310-102-04

B CLEAN HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78310-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL154 g  in 220 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MENTHA PIPERITA (UNII: 79M2M2UDA9)  
ISOPROPANOLAMINE (UNII: UE40BY1BZW)  
VERBENA OFFICINALIS LEAF (UNII: 3289NQE84P)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
SAGE (UNII: 065C5D077J)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78310-102-03220 g in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
2NDC:78310-102-04220 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/12/2020
3NDC:78310-102-07104 g in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
4NDC:78310-102-0852 g in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
5NDC:78310-102-051320 g in 1 KIT; Type 0: Not a Combination Product07/31/2020
6NDC:78310-102-061320 g in 1 KIT; Type 0: Not a Combination Product07/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/12/2020
Labeler - HETH LLC (080815601)
Registrant - AGE DO BRASIL INDUSTRIA E COMERCIO LTDA. (920307841)
Establishment
NameAddressID/FEIBusiness Operations
AGE DO BRASIL INDUSTRIA E COMERCIO LTDA.920307841manufacture(78310-102)

Revised: 8/2020
Document Id: abf992bb-c4be-5852-e053-2a95a90a3917
Set id: a7d1eb82-9196-365e-e053-2995a90aad0c
Version: 5
Effective Time: 20200803
 
HETH LLC