B CLEAN PREMIUM HAND SANITIZER- ethyl alchol gel

b Clean Premium Hand Sanitizer by

Drug Labeling and Warnings

b Clean Premium Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by B Holding Group LLC, Nantong Health & Beyond Hygienic Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• in children less than 2 months of age
• on open skin wounds

WHEN USING

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

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

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

• Do not store above 110°F
• May discolor some fabrics

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

INGREDIENTS AND APPEARANCE

B CLEAN PREMIUM HAND SANITIZER 
ethyl alchol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78396-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78396-001-59	59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - B Holding Group LLC (006108561)

Registrant - B Holding Group LLC (006108561)

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture(78396-001)