CLEANSING DISINFECTION WIPES cloth

CLEANSING DISINFECTION WIPES by

Drug Labeling and Warnings

CLEANSING DISINFECTION WIPES by is a Otc medication manufactured, distributed, or labeled by Guangdong Bolicen Bio-Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 10% w/w

Benzalkonium Chlorid 0. 1%w/w

Poly( hexamethylenebiguanide )hydro-chloride 0.05%w/w

Didecyl Dimethylammonium Chloride 0.3%w/w

Purpose

Antiseptic

Use

USE FOR HAND AND SKIN SURFACE DISINFECTING AND CLEANSING

Warnings

For extemal use only. Keep away from sunlight, store in a cool, dry place

Do not use

In children less than 2 months of age
On open skin wounds

WHEN USING

When using this product keep out of eyes and sore or broken skin, If contact with eyes occurs, rinse thoroughly with water.top use and ask a doctor if irritation or rash occurs, These may be signs of a serious condition Keep out of reach of children. Get medical help or contact a Poison Control Center right away if needed

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. Get medical help or contact a Poison Control Center right away if needed

Directions

Open lid, For first time user, remove tamper evident seal, Pullout wipes as needed. Close the lid after use each time top revent moisture loss

Other information

Do not store above 40 °C. May discolor some fabrics and surfaces
Store between15-30°C

Inactive ingredients

Water

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

CLEANSING DISINFECTION WIPES 
cleansing disinfection wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78293-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1   in 100
POLIHEXANIDE (UNII: 322U039GMF) (POLIHEXANIDE - UNII:322U039GMF)	POLIHEXANIDE	0.05   in 100
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	10   in 100
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA)	DIDECYLDIMONIUM CHLORIDE	0.3   in 100

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78293-008-01	8 in 1 BAG; Type 0: Not a Combination Product	07/12/2020
2	NDC: 78293-008-02	10 in 1 BAG; Type 0: Not a Combination Product	07/12/2020
3	NDC: 78293-008-03	30 in 1 BAG; Type 0: Not a Combination Product	07/12/2020
4	NDC: 78293-008-04	50 in 1 BAG; Type 0: Not a Combination Product	07/12/2020
5	NDC: 78293-008-05	80 in 1 BAG; Type 0: Not a Combination Product	07/12/2020
6	NDC: 78293-008-06	100 in 1 BAG; Type 0: Not a Combination Product	07/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/12/2020

Labeler - Guangdong Bolicen Bio-Technology Co., Ltd. (554525110)

Establishment
Name	Address	ID/FEI	Business Operations
Guangdong Bolicen Bio-Technology Co., Ltd.		554525110	manufacture(78293-008)