75% ALCOHOL HAND SANITIZER gel

75% ALCOHOL HAND SANITIZER by

Drug Labeling and Warnings

75% ALCOHOL HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by PHOENYX DISTRIBUTING, LLC, Fortress Expert Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 75% v/v.

Purpose

Antiseptic

Use

Helps reduce bacea at pontentially can caus dsease

Helps prevent Cross contamination on contact

Recommended for repeated use

Warnings

For external use only

Flammable, Keep away from fire or flame

Do not use near eyesIn case of eye contact flush with water for 15 minutes

If imitation persists stop use of product and get medical attention

Keep out of reach of childrenIn case of accidental ingestion seek medical attention orcontact a poison contro center immediately

Do not use

• Do not use in or near the eyes. In case of contact with eyes flush thoroughly with water for 15 minutes

WHEN USING

When using this product

Do not use in or near the eyes. In case of contact with eyes flush thoroughly with water

STOP USE

/

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. case of accidental ingestion seek medical attention orcontact a poison contro center immediately

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

/

Inactive ingredients

Water(Aqua), PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,
Fragrance (Parfum) Aminomethyl Propanol

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

75% ALCOHOL HAND SANITIZER 
75% alcohol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79316-008
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79316-008-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 79316-008-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - PHOENYX DISTRIBUTING, LLC (128029831)

Establishment
Name	Address	ID/FEI	Business Operations
PHOENYX DISTRIBUTING, LLC		128029831	label(79316-008)

Establishment
Name	Address	ID/FEI	Business Operations
Fortress Expert Co., Ltd		543358697	manufacture(79316-008)