ANTIBACTERIAL INSTANT HAND SANITIZER- hand sanitizer gel

Antibacterial Instant Hand Sanitizer by

Drug Labeling and Warnings

Antibacterial Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by INTENTLY (GUANGZHOU) BIOTECHNOLOGY CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Avoid direct sunlight and high temperatures. Store below 30°C

INACTIVE INGREDIENT

Water、Carbomer、Triethanolamine

INDICATIONS & USAGE

Wet hands thoroughly with product and allow to dry without wiping. Supervise children in the use of this product.

ACTIVE INGREDIENT

Alcohol

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children

PURPOSE

Disinfection
Sterilization
No Rinseing

WARNINGS

For external use only.Flammable.Keep away from fire or flame.Do not use in the eyes.In case of contact,rinse eyes thoroughly with water.Discontinue use if skin irritation develops. If condition persists for more than 72 hours consult a doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL INSTANT HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55467-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55467-015-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020
2	NDC: 55467-015-02	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020
3	NDC: 55467-015-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020
4	NDC: 55467-015-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020
5	NDC: 55467-015-05	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020
6	NDC: 55467-015-06	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020
7	NDC: 55467-015-07	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020
8	NDC: 55467-015-08	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020
9	NDC: 55467-015-09	3780 mL in 1 PAIL; Type 0: Not a Combination Product	06/17/2020
10	NDC: 55467-015-10	1000000 mL in 1 PAIL; Type 0: Not a Combination Product	06/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/17/2020

Labeler - INTENTLY (GUANGZHOU) BIOTECHNOLOGY CO., LTD. (554531968)

Establishment
Name	Address	ID/FEI	Business Operations
INTENTLY (GUANGZHOU) BIOTECHNOLOGY CO., LTD.		554531968	manufacture(55467-015)