TongYi CleanGuard Hand Sanitizer: Package Insert and Label Information

TONGYI CLEANGUARD HAND SANITIZER- alcohol gel
Tongyi Petroleum Chemical Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Active ingredient

Ethanol

Inactive ingredient

Water

Acrylate

Purpose

Effectively kill intestinal pathogenic bacteria, pyogenic coccus, pathogenic yeast and common pathogenic bacteria in hospital.

When using

Effectively kill intestinal pathogenic bacteria, pyogenic coccus, pathogenic yeast and common pathogenic bacteria in hospital.

Do not use

Use only as directed.
Do not use for cases not directed.

Stop use

Stop use if the product’s volatile gases cause discomfort, or if you experience respiratory irritation such as cough, asthma, or difficulty breathing.

Ask doctor

If using the product causes serious discomfort, ask or see your doctor.

Ask doctor/pharmacist

If using the product causes serious discomfort, ask or see your doctor/pharmacist.

Keep out of reach of children

Keep out of reach of children.

Questions

Please contact with us at the phone number +86-10-61238999 when you have any questions.

Pregnancy or breast feeding

Pregnant or breast feeding women shall follow doctor advice.

Indications & usage

1. Hygiene hand disinfection: take an appropriate amount of instant hand sanitizing gel on the palm of your hand, rub your hands for 1 minute.

2. Surgical hand disinfection: wash and dry the lower 1/3 of the hands, forearms and upper arms with soap or antibacterial hand sanitizer according to the instruction, and then apply 5-10ml of this product evenly to the hands, forearms and lower 1/3 of the upper arms. Rub the skin to dryness and wait for 3 minutes before wearing sterile gloves.

Dosage & administration

Use it as needed, after following the usage instructions.

For external use only.

Dosage forms & strengths

This product is gel dosage form.
The active ingredient strength is 70%.

Warnings

1. For external use and shall not be taken orally; keep out of reach of children.

2. Use with caution if allergic to alcohol; Seek for timely medical treatment if untoward reaction occurs in the use.

3. This product contains alcohol, avoid open flames; keep tightly closed in a cool place.

4. Keep away from the eyes, do not rub the eyes if accidental contact, rinse the eyes thoroughly with water for 15 minutes. If the situation worsens or irritation continues, seek medical treatment. Do not induce vomiting if swallow occurs, see medical treatment from hospital or poison control center.

5. This product should not be used for damaged skin. For external use only, avoid entering into the eyes.

Package label. Principal display panel

TONGYI CLEANGUARD HAND SANITIZER hand sanitizer gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73681-6061 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 42 mL in 60 mL

Inactive Ingredients Ingredient Name Strength 1,3-BUTYLENEGLYCOL DIMETHACRYLATE 5 mL in 60 mL WATER 15 mL in 60 mL

Product Characteristics Color Score Shape FREEFORM Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73681-6061-7 96 BOTTLE, PUMP in 1 BOX contains a BOTTLE, PUMP (73681-6061-1) 1 NDC:73681-6061-1 60 mL in 1 BOTTLE, PUMP This package is contained within the BOX (73681-6061-7)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/01/2020

Labeler — Tongyi Petroleum Chemical Co., Ltd. (544924178)

Registrant — Tongyi Petroleum Chemical Co., Ltd. (544924178)

Establishment
Name	Address	ID/FEI	Operations
Tongyi Petroleum Chemical Co., Ltd.		544924178	label (73681-6061), manufacture (73681-6061)

Revised: 04/2020 Tongyi Petroleum Chemical Co., Ltd.