SHIERJIE DISINFECTING SOFT WIPES ANTIBACTERIAL cloth

SHIERJIE DISINFECTING SOFT WIPES Antibacterial by

Drug Labeling and Warnings

SHIERJIE DISINFECTING SOFT WIPES Antibacterial by is a Otc medication manufactured, distributed, or labeled by Shenzhen Shierjie Biological Engineering Co., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.09%
Dodecyl Dimethyl Ammonium Chloride 0.04 %

Purpose

Antimicrobial

INDICATIONS & USAGE

Decreases bacteria on skin

Warnings

For external use only.Keep away from heat or flame.

DO NOT USE

If you are allergic to any of the ingredients.If children less than 2 months of age.

WHEN USING

When using this produc, do not get into eyes.If contact occurs, rinse thoroughly with water.

STOP USE

Stop use and ask a doctor if iri tation or rash develops and continues for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

If swallowed,get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years and over
Apply to hands
Allow to dry without wiping
Children under 2 years
Ask a doctor before use

Other information

/

Inactive ingredients

Aloe Barbadensis Extract , Glycerin , Aqua , Non-woven

Package Label - Principal Display Panel

43116-004-01 1P

43116-004-02 10P

43116-004-03 40P

43116-004-04 50P

43116-004-05 60P

43116-004-06 80P

43116-004-07 90P

43116-004-08 100P

43116-004-09 120P

43116-004-10 60P

43116-004-11 80P

43116-004-12 100P

43116-004-13 120P

43116-004-14 160P

43116-004-15 1000P

INGREDIENTS AND APPEARANCE

SHIERJIE DISINFECTING SOFT WIPES ANTIBACTERIAL 
shierjie disinfecting soft wipes antibacterial cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43116-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.09 g  in 100
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA)	DIDECYLDIMONIUM CHLORIDE	0.04 g  in 100

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA FLOWER (UNII: 575DY8C1ER)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43116-026-01	1 in 1 BAG; Type 0: Not a Combination Product	03/31/2020
2	NDC: 43116-026-02	10 in 1 BAG; Type 0: Not a Combination Product	03/31/2020
3	NDC: 43116-026-03	40 in 1 BAG; Type 0: Not a Combination Product	03/31/2020
4	NDC: 43116-026-04	50 in 1 BAG; Type 0: Not a Combination Product	03/31/2020
5	NDC: 43116-026-05	60 in 1 BAG; Type 0: Not a Combination Product	03/31/2020
6	NDC: 43116-026-06	80 in 1 BAG; Type 0: Not a Combination Product	03/31/2020
7	NDC: 43116-026-07	90 in 1 BAG; Type 0: Not a Combination Product	03/31/2020
8	NDC: 43116-026-08	100 in 1 BAG; Type 0: Not a Combination Product	03/31/2020
9	NDC: 43116-026-09	120 in 1 BAG; Type 0: Not a Combination Product	03/31/2020
10	NDC: 43116-026-10	60 in 1 DRUM; Type 0: Not a Combination Product	03/31/2020
11	NDC: 43116-026-11	80 in 1 DRUM; Type 0: Not a Combination Product	03/31/2020
12	NDC: 43116-026-12	100 in 1 DRUM; Type 0: Not a Combination Product	03/31/2020
13	NDC: 43116-026-13	120 in 1 DRUM; Type 0: Not a Combination Product	03/31/2020
14	NDC: 43116-026-14	160 in 1 DRUM; Type 0: Not a Combination Product	03/31/2020
15	NDC: 43116-026-15	1000 in 1 DRUM; Type 0: Not a Combination Product	03/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/31/2020

Labeler - Shenzhen Shierjie Biological Engineering Co., LTD (547610261)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Shierjie Biological Engineering Co., LTD		547610261	manufacture(43116-026)