Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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 this product

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

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) Acryatesc10-30 Alkyl Acrylate Crosspoymer Aminomethyl Propanol

Package Label - Principal Display Panel

75% ALCOHOL HAND SANITIZER
75% alcohol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79316-007
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79316-007-08	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:79316-007-06	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:79316-007-07	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC:79316-007-05	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC:79316-007-04	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC:79316-007-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC:79316-007-09	950 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
8	NDC:79316-007-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
9	NDC:79316-007-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
10	NDC:79316-007-10	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

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

Labeler - PHOENYX DISTRIBUTING, LLC (128029831)

Name	Address	ID/FEI	Business Operations
Establishment
PHOENYX DISTRIBUTING, LLC		128029831	label(79316-007)

Name	Address	ID/FEI	Business Operations
Establishment
Fortress Expert Co., Ltd		543358697	manufacture(79316-007)