Advanced Hand Sanitizer Gel: Package Insert and Label Information

ADVANCED HAND SANITIZER GEL- alcohol gel
Bozhou Xunhetang Biological Technology Co., Ltd.

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.

ADVANCED HAND SANITIZER GEL

Active Ingredient(s)

Alcohol 75% 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

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water
aloe
CARBOMER HOMOPOLYMER
Trolamine
Tocopheryl Acetate
(Vitamin E)

Package Label — Principal Display Panel

ADVANCED HAND SANITIZER GEL alcohol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78254-111 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 100 mL

Inactive Ingredients Ingredient Name Strength ALOE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE WATER TROLAMINE .ALPHA.-TOCOPHEROL ACETATE, D-

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:78254-111-01 30 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/01/2021

Labeler — Bozhou Xunhetang Biological Technology Co., Ltd. (554533192)

Establishment
Name	Address	ID/FEI	Operations
Bozhou Xunhetang Biological Technology Co., Ltd.		554533192	manufacture (78254-111)

Revised: 02/2021 Bozhou Xunhetang Biological Technology Co., Ltd.