B Clean Premium Hand Sanitizer: Package Insert and Label Information

B CLEAN PREMIUM HAND SANITIZER- alcohol 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.

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

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 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

• 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

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 100 mL

Inactive Ingredients Ingredient Name Strength TROLAMINE PROPYLENE GLYCOL CARBOMER INTERPOLYMER TYPE A (55000 CPS) MALTODEXTRIN GLYCERIN ALOE VERA LEAF WATER .ALPHA.-TOCOPHEROL ACETATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:78396-001-59 59 mL in 1 BOTTLE, DISPENSING None

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	Operations
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture (78396-001)

Revised: 05/2020 B Holding Group LLC