HAND SANITIZER by Fortress Expert Co., Ltd HAND SANITIZER gel

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Fortress Expert Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 75.05%

​Purpose

Antiseptic

Uses

Helps reduce bacteria that potentially can cause disease

Helps prevent cross contamination by hand contact

Recommended for repeated use

Warnings

For external use only

Flammable, keep away from fire, heat,or flame

Do not use near eyes

In case of eye contact flush with water for 15 minutes

if irritation persists stop use of product and get medical attention

Keep out of reach of children.

In case of accidental ingestion seek medical attention or contact a poison control center immediately.

DO NOT USE

WHEN USING

STOP USE

KEEP OUT OF REACH OF CHILDREN

Directions

Wet hands thoroughly with product and and rub completely covering hands

Allow to dry without wiping

Children under the age of 6 should use with adult

supervision

Not recommended for infants

Other information

Inactive Ingredients

Water, PEG-40 Hydrogenated Castor Oil, Carbomer,

Fragrance (Parfum), Triethanolamine, Triisopropanolamine

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73549-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75.05 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
TROLAMINE (UNII: 9O3K93S3TK)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73549-005-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2020
2	NDC: 73549-005-02	946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2020
3	NDC: 73549-005-03	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2020
4	NDC: 73549-005-04	3785.4 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/10/2020

Labeler - Fortress Expert Co., Ltd (543358697)

Registrant - Fortress Expert Co., Ltd (543358697)

Establishment
Name	Address	ID/FEI	Business Operations
Fortress Expert Co., Ltd		543358697	manufacture(73549-005)