Active Ingredient(s)

Benzalkonium Chloride 0.13% w/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.

Do not use

on open wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

water, isopropyl alcohol, hydroxyethyl cellulose, glycerin, methylparabene, propylparabene, propylene glycol, DMDM Hydantoin, FD&C Blue No 1

Package Label - Principal Display Panel

1000 mL NDC: 77143-003-01 nat 1L

500 mL NDC: 77143-003-02 nat 500 mL

250 mL NDC: 77143-003-03 nat 250

5000 mL NDC: 77143-003-04 5 L

1000 mL NDC: 77143-003-05 Alpha 1L

1000 mL NDC: 77143-003-06 CP 1L

500 mL NDC: 77143-003-07 CP 500mL

500 mL NDC: 77143-003-08 Alpha 500ml

250 mL NDC: 77143-003-09 Alpha 250

5000 mL NDC: 77143-003-10 alpha 5L

3785 mL NDC: 77143-003-11 CP gal

5000 mL NDC: 77143-003-12 Q5L

250 mL NDC: 77143-003-13

PDP 250 ML

500 mL NDC: 77143-003-14

PDP 500ML

1000 mL NDC: 77143-003-15

PDP 1L

3785 mL NDC: 77143-003-16 gal quarter

3785 mL NDC: 77143-003-17 Natgal

100 mL NDC: 77143-003-22

PDP 100ML

250 mL NDC: 77143-003-21

PDP 250 ML

HAND SANITIZER
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77143-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ISOPROPYL ALCOHOL (UNII: ND2M416302)	10 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.25 mL in 100 mL
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)	0.01 g in 100 mL
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)	0.025 g in 100 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.025 g in 100 mL
DMDM HYDANTOIN (UNII: BYR0546TOW)	0.025 g in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.001 g in 100 mL
DIPROPYLENE GLYCOL (UNII: E107L85C40)	0.025 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77143-003-05	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	11/23/2020
2	NDC:77143-003-10	5000 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020	11/23/2020
3	NDC:77143-003-06	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC:77143-003-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC:77143-003-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC:77143-003-03	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC:77143-003-04	5000 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020
8	NDC:77143-003-07	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
9	NDC:77143-003-08	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	11/23/2020
10	NDC:77143-003-09	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	11/23/2020
11	NDC:77143-003-11	3785 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020	11/23/2020
12	NDC:77143-003-12	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
13	NDC:77143-003-13	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
14	NDC:77143-003-14	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
15	NDC:77143-003-15	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
16	NDC:77143-003-16	3785 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020
17	NDC:77143-003-17	3785 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020
18	NDC:77143-003-22	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
19	NDC:77143-003-21	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/04/2020

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

Labeler - NATURATLALI S DE RL DE CV (951577202)

Registrant - NATURATLALI S DE RL DE CV (951577202)

Name	Address	ID/FEI	Business Operations
Establishment
NATURATLALI S DE RL DE CV		951577202	manufacture(77143-003) , pack(77143-003) , label(77143-003)