ANTISEPTIC SANITIZING WIPES (0.13% BENZALKONIUM CHLORIDE)- benzalkonium chloride cloth

Antiseptic sanitizing wipes (0.13% Benzalkonium Chloride) by

Drug Labeling and Warnings

Antiseptic sanitizing wipes (0.13% Benzalkonium Chloride) by is a Otc medication manufactured, distributed, or labeled by Jintu Handicraft Factory, A03 Lab of BTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride 0.13% w/w. Purpose: Antiseptic

Purpose

Antiseptic

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Do not use

• in children less than 2 months of age
• on open skin

STOP USE

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

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

Directions

Unfold towelette, wipe hands, discard after use.

Rub thoroughly into hands for at least 30 seconds, allow to dry.

Directions

Peel back flap on front to pull out a wipe.

Unfold and wipe hands thoroughly.

Reseal and let hands dry.

No need to rinse.

Warnings

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

• Do not replace wipes used for medical procedures.
• These wipes are meant for general cleansing.

Other information

Store between 15-30℃ (59-86℉)

Inactive ingredients

purified water USP

Package label. Principal display panel

INGREDIENTS AND APPEARANCE

ANTISEPTIC SANITIZING WIPES (0.13% BENZALKONIUM CHLORIDE) 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79846-151
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	5.2 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79846-151-21	50 in 1 POUCH; Type 0: Not a Combination Product	07/27/2020
2	NDC: 79846-151-23	60 in 1 POUCH; Type 0: Not a Combination Product	07/27/2020
3	NDC: 79846-151-25	72 in 1 POUCH; Type 0: Not a Combination Product	07/27/2020
4	NDC: 79846-151-27	80 in 1 POUCH; Type 0: Not a Combination Product	07/27/2020
5	NDC: 79846-151-31	100 in 1 POUCH; Type 0: Not a Combination Product	07/27/2020
6	NDC: 79846-151-50	100 in 1 PAIL; Type 0: Not a Combination Product	07/27/2020
7	NDC: 79846-151-52	120 in 1 PAIL; Type 0: Not a Combination Product	07/27/2020
8	NDC: 79846-151-56	160 in 1 PAIL; Type 0: Not a Combination Product	07/27/2020
9	NDC: 79846-151-58	180 in 1 PAIL; Type 0: Not a Combination Product	07/27/2020
10	NDC: 79846-151-60	200 in 1 PAIL; Type 0: Not a Combination Product	07/27/2020
11	NDC: 79846-151-90	500 in 1 PAIL; Type 0: Not a Combination Product	07/27/2020
12	NDC: 79846-151-05	10 in 1 POUCH; Type 0: Not a Combination Product	11/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/27/2020

Labeler - Jintu Handicraft Factory (654443675)

Registrant - A03 Lab of BTS (548009541)

Establishment
Name	Address	ID/FEI	Business Operations
Jintu Handicraft Factory		654443675	manufacture(79846-151) , label(79846-151)