SANITARY WET WIPES cloth

SANITARY WET WIPES by

Drug Labeling and Warnings

SANITARY WET WIPES by is a Otc medication manufactured, distributed, or labeled by Dandong Xinshidai Biotec Pharmaceuticals Co.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium chloride 0.13% w/w

Purpose

Antiseptic

Uses

Suitable for wiping hands, face, skin and other unbroken skin.

Warnings

For external use only.

When using this product avoid to contact eyes, wounds and other sensitive parts. 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.

This product is insoluble in water, please put it in the trash after use.

WHEN USING

When using this product avoid to contact eyes, wounds and other sensitive parts. In case of contact with eyes, rinse eyes thoroughly with water.

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

Take out the wet wipes and use directly

Other Information

· Store in a cool place, avoid sunlight or high temperature.

· Shelf Life: 2 years

· Product specification: 160mm × 200mm

· Product features: pure cotton texture, soft and comfortable

It has bactericidal effect on Staphylococcus aureus, Escherichia coli and Candida albicans.

· See the code on the package for the expiration date and production lot number

Inactive Ingredients

RO water, Bronopol

PRINCIPAL DISPLAY PANEL

Net Contents: 1 PCS; NDC: 81306-001-01

Net Contents: 10PCS; NDC: 81306-001-02

Net Contents: 60PCS; NDC: 81306-001-03

Net Contents: 72PCS; NDC: 81306-001-04

Net Contents: 80PCS; NDC: 81306-001-05

Net Contents: 100PCS; NDC: 81306-001-06

INGREDIENTS AND APPEARANCE

SANITARY WET WIPES 
sanitary wet wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81306-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BRONOPOL (UNII: 6PU1E16C9W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81306-001-01	1 in 1 BAG	11/06/2020
1		5.5 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 81306-001-02	10 in 1 BAG	11/06/2020
2		5.5 g in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 81306-001-03	60 in 1 BAG	11/06/2020
3		5.5 g in 1 PATCH; Type 0: Not a Combination Product
4	NDC: 81306-001-04	72 in 1 BAG	11/06/2020
4		5.5 g in 1 PATCH; Type 0: Not a Combination Product
5	NDC: 81306-001-05	80 in 1 BAG	11/06/2020
5		5.5 g in 1 PATCH; Type 0: Not a Combination Product
6	NDC: 81306-001-06	100 in 1 BAG	11/06/2020
6		5.5 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/06/2020

Labeler - Dandong Xinshidai Biotec Pharmaceuticals Co.,LTD (527128186)

Registrant - Dandong Xinshidai Biotec Pharmaceuticals Co.,LTD (527128186)

Establishment
Name	Address	ID/FEI	Business Operations
Dandong Xinshidai Biotec Pharmaceuticals Co.,LTD		527128186	manufacture(81306-001) , label(81306-001) , pack(81306-001)