HAND SANITIZER by FUJIAN LZY BIOTECHNOLOGY CO., LTD. / A03 Lab of BTS HAND SANITIZER liquid

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by FUJIAN LZY BIOTECHNOLOGY CO., LTD., A03 Lab of BTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Uses

● Hand sanitizer to help reduce bacteria that potentially can cause disease.
● Antiseptic for hands and skin.
● Sanitize hands and skin when water and soap are not available.

Warnings

For external use only. DO NOT INGEST.

Warning: Flammable. Do not use near open flame, fire or spark.

Do not use

● On infants under 2 months old.
● On open skin or puncture-type wounds.
● Near or in eyes. If eye contact occurs, flush with cold water.
Seek medical attention if irritation persists.

WHEN USING

Supervise children under 6 years of age when using sanitizer to avoid swallowing.

STOP USE

Stop using if irritation appears.
Seek medical attention if irritation persists.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

Directions for use

● Clean hands and skin with hand sanitizer.
● No need to rinse, let hands or skin dry.

Other information

● Read all directions and warnings before using hand sanitizer.
● Store at room temperature 15 to 30 °C (59 to 86 °F) with bottle closed.
● Avoid excessive heat above 40 °C (104 °F).

Inactive ingredients

Aqua (purified water), Carbomer, Glycerin, Triethanolamine.

Any questions?

Please call (888) 712 8988.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42100-001
Route of Administration	EXTRACORPOREAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	375 mL  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code	SAFECARE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42100-001-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/02/2020

Labeler - FUJIAN LZY BIOTECHNOLOGY CO., LTD. (421000502)

Registrant - A03 Lab of BTS (548009541)

Establishment
Name	Address	ID/FEI	Business Operations
FUJIAN LZY BIOTECHNOLOGY CO., LTD.		421000502	manufacture(42100-001)