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 62%

Purpose

Antiseptic

Uses

Helps reduce bacteria that potentially can cause disease

Helps prevent cross contamination on contact

Recommended for repeated use

Warnings

Flammable, keep away from open flame and sources of heat

External use only

Avoid contact with eyes , in the case of eyes contact, rinse eyes thoroughly with water.

Stop use and consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops

Keep out of reach of children

DO NOT USE

Avoid contact with eyes , in the case of eyes contact, rinse eyes thoroughly with water.

WHEN USING

STOP USE

Stop use and consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops

Keep out of reach of children

Keep out of reach of children

If swallowed, call a poison control center or get medical help right away .

Directions

Wet hands thoroughly with product 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

Store below 105F(41C)

May discolor certain fabrics or surfaces.

Inactive ingredients

Water, Acrylates/C10- Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance

PEG-40 Hydrogenated Castor Oil. May man FD&C RED NO 4( 14700), D& REN0.33(C 17200), FD&C YELLOW NO 5(C 19140), FD&C BLUE NO. 1(CI 42090)

Package Label Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73549-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73549-008-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/23/2020
2	NDC: 73549-008-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/23/2020
3	NDC: 73549-008-03	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/23/2020
4	NDC: 73549-008-04	1800 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/23/2020

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(73549-008)