GASTRODIA ELATA PEPTIDE HAND SANITIZING- hand sanitizer gel

Gastrodia elata Peptide Hand Sanitizing by

Drug Labeling and Warnings

Gastrodia elata Peptide Hand Sanitizing by is a Otc medication manufactured, distributed, or labeled by Tonghua Ren-Sheng-Yuan Biotechnology Co., Ltd, A03 Lab of BTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic.

Gastrodia elata Blume peptide 5.5% v/v. Purpose: bactericidal against Candida albicans, Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli.

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.

Used for hand sanitizing and surgical hand sanitizing.

Warnings

1. External use of disinfection gel. Ban on oral. Keep this container out of the reach of children.
2. Avoid use with antagonistic drugs.
3. Caution for allergic people.
4. Keep away from the source of fire due to its inflammable.
5. Seal, and store in a cool and dry place.

Do not use

• on children less than 2 months of age
• on open skin wounds
• in the eyes. in case of contact, rinse eyes thoroughly with water

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

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

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

1.Sanitary hand disinfection: Take the right amount of this product on the palm, both hands rub each other to make uniform coating on each part for 1 minute.
2. Surgical hand antisepsis: After surgical hand washing, apply proper amount of this product evenly to the skin of the forearm and the lower third of the upper arm of both hands and rub for 3 to 5 minutes until dry.

Other information

Seal, and store in a cool and dry place.

Inactive ingredients

Water, Glycerine.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

GASTRODIA ELATA PEPTIDE HAND SANITIZING 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75449-1001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GASTRODIA ELATA WHOLE (UNII: ZK2B063E7Q) (GASTRODIA ELATA WHOLE - UNII:ZK2B063E7Q)	GASTRODIA ELATA WHOLE	27.5 g  in 500 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	350 mL  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75449-1001-1	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/24/2020

Labeler - Tonghua Ren-Sheng-Yuan Biotechnology Co., Ltd (554530164)

Registrant - A03 Lab of BTS (548009541)

Establishment
Name	Address	ID/FEI	Business Operations
Tonghua Ren-Sheng-Yuan Biotechnology Co., Ltd		554530164	label(75449-1001) , manufacture(75449-1001)