Active Ingredient(s)

Benzalkonium Chloride 0.2%

Purpose

Antimicrobial

Use

Kills 99.99% of germs.

Warnings

For external use only. Keep out of eyes.
In case of eye contact, rinse eyes with water.

Stop use and ask a doctor if redness or irritation develops.
Keep out of sunlight.

Keep out of reach of children.

Directions

Peel back flap on front to pull out a towelette. Reseal the flap. No need ro rinse.

Inactive ingredients

Water，Glycerin，Propylene Glycol，Polyaminopropyl Biguanide，Phenoxyethanol ，Iodopropynyl Butylcarbamate，Green Tea Extract.

100 Package Label - Principal Display Panel

100 label front 100 label back

80 Package Label - Principal Display Panel

80 label front 80 label back

40 Package Label - Principal Display Panel

label-40 front

label-40 back

20 Package Label - Principal Display Panel

20 label front 20 label back

10 Package Label - Principal Display Panel

10 label

400 Pail Label - Principal Display Panel

NDC:76635-001-06

400 label

NDC:76635-001-07

label-400-2

NDC:76635-001-09

label-400-3

1 Package Label - Principal Display Panel

label-1 wipe1 label-1 wipe2

70 Package Label - Principal Display Panel

label-70-1 label-70-2

250 Pail Package Label - Principal Display Panel

NDC:76635-001-11

label 250 in 1 pail-1 label 250 in 1 pail-2

100 Pail Package Label - Principal Display Panel

NDC:76635-001-12

label 100 in 1 pail-1 label 100 in 1 pail-2 label 100 in 1 pail-3

ANTIBACTERIAL WIPES
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76635-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76635-001-01	432 g in 1 BAG; Type 0: Not a Combination Product	05/01/2020
2	NDC:76635-001-02	346 g in 1 BAG; Type 0: Not a Combination Product	05/01/2020
3	NDC:76635-001-03	173 g in 1 BAG; Type 0: Not a Combination Product	05/01/2020
4	NDC:76635-001-04	87 g in 1 BAG; Type 0: Not a Combination Product	05/01/2020
5	NDC:76635-001-05	47 g in 1 BAG; Type 0: Not a Combination Product	05/10/2020
6	NDC:76635-001-06	1700 g in 1 PAIL; Type 0: Not a Combination Product	05/10/2020
7	NDC:76635-001-07	1700 g in 1 PAIL; Type 0: Not a Combination Product	05/28/2020
8	NDC:76635-001-08	4.3 g in 1 BAG; Type 0: Not a Combination Product	07/25/2020
9	NDC:76635-001-09	1700 g in 1 PAIL; Type 0: Not a Combination Product	08/10/2020
10	NDC:76635-001-10	303 g in 1 BAG; Type 0: Not a Combination Product	08/29/2020
11	NDC:76635-001-11	1215 g in 1 PAIL; Type 0: Not a Combination Product	10/08/2020
12	NDC:76635-001-12	480 g in 1 PAIL; Type 0: Not a Combination Product	10/08/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	05/01/2020

Labeler - Hangzhou Glamcos Biotech CO.,LTD (554476017)

Registrant - Hangzhou Glamcos Biotech CO.,LTD (554476017)

Name	Address	ID/FEI	Business Operations
Establishment
Hangzhou Glamcos Biotech CO.,LTD		554476017	manufacture(76635-001)