B CLEAN PREMIUM HAND SANITIZER- ethyl alchol gel 
B Holding Group 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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This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

  1. Ethyl Alcohol (62%, v/v)
  2. Water (36.228% v/v).
  3. ALOE Barbadensis Leaf Juice
  4. Maltodextrin
  5. Glycerin
  6. Propylene Glycol
  7. Fragrance
  8. Acrylates/c10-30 Alkyl Arcylate Crosspolymer
  9. Triethanomine
  10. Tocopheryl Acetate

Active Ingredient(s)

Ethyl Alcohol 62% 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

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 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

Water (36.228% v/v).
ALOE Barbadensis Leaf Juice
Maltodextrin
Glycerin
Propylene Glycol
Fragrance
Acrylates/c10-30 Alkyl Arcylate Crosspolymer
Triethanomine
Tocopheryl Acetate

Package Label - Principal Display Panel

Fornt and Back label

B CLEAN PREMIUM HAND SANITIZER 
ethyl alchol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78396-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78396-001-5959 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - B Holding Group LLC (006108561)
Registrant - B Holding Group LLC (006108561)
Establishment
NameAddressID/FEIBusiness Operations
Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(78396-001)

Revised: 5/2020
Document Id: a68b1255-7b2a-b963-e053-2a95a90a5d28
Set id: a72ca993-1887-96f5-e053-2995a90ad463
Version: 2
Effective Time: 20200526
 
B Holding Group LLC