SANITIZING WIPES- benzalkonium chloride,polyaminopropyl biguanide cloth

Sanitizing wipes by

Drug Labeling and Warnings

Sanitizing wipes by is a Otc medication manufactured, distributed, or labeled by NanTong Guarder Medical Technology Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium chloride 0.3% w/v

Polyaminopropyl biguanide 0.1% w/v.

Purpose: Antiseptic

Purpose

Antiseptic

Use

• For hand and skin cleaning
• Recommended for repeated use
• For use when soap and water are not available

Warnings

For external use only. Avoid contact around the eyes. If contact occurs, flush eyes with water. If the condition persists, consult a doctor. If swallowed immediately call a poison control center or a doctor for treatment advice.

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, ears, and mouth. 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.

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

Wet hands thoroughly with product and allow to dry.

Dicard wipes in trash receptacle after use. Do not flush.

Children under 6 years of age should be supervised when using this product.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, Glycerine, Decyl Glucoside, Aloe Vera, Fructooligosaccharide, Fragrance

Package Label - Principal Display Panel

5wipes in one box NDC: 79795-004-02

INGREDIENTS AND APPEARANCE

SANITIZING WIPES 
benzalkonium chloride,polyaminopropyl biguanide cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79795-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET) (POLYAMINOPROPYL BIGUANIDE - UNII:DT9D8Z79ET)	POLYAMINOPROPYL BIGUANIDE	0.1 g  in 100
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.3 g  in 100

Inactive Ingredients
Ingredient Name	Strength
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79795-004-01	3 in 1 BAG; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	11/06/2020
2	NDC: 79795-004-02	5 in 1 BAG; Type 0: Not a Combination Product	11/06/2020
3	NDC: 79795-004-03	10 in 1 BAG; Type 0: Not a Combination Product	11/06/2020
4	NDC: 79795-004-04	20 in 1 BAG; Type 0: Not a Combination Product	11/06/2020
5	NDC: 79795-004-05	50 in 1 BAG; Type 0: Not a Combination Product	11/06/2020
6	NDC: 79795-004-06	80 in 1 BAG; Type 0: Not a Combination Product	11/06/2020
7	NDC: 79795-004-07	75 in 1 BOX; Type 0: Not a Combination Product	11/06/2020
8	NDC: 79795-004-08	80 in 1 BOX; Type 0: Not a Combination Product	11/06/2020
9	NDC: 79795-004-09	100 in 1 BOX; Type 0: Not a Combination Product	11/06/2020
10	NDC: 79795-004-10	150 in 1 BOX; Type 0: Not a Combination Product	11/06/2020
11	NDC: 79795-004-11	160 in 1 BOX; Type 0: Not a Combination Product	11/06/2020
12	NDC: 79795-004-12	200 in 1 BOX; Type 0: Not a Combination Product	11/06/2020
13	NDC: 79795-004-13	600 in 1 BOX; Type 0: Not a Combination Product	11/06/2020
14	NDC: 79795-004-14	800 in 1 BOX; Type 0: Not a Combination Product	11/06/2020
15	NDC: 79795-004-15	1000 in 1 BOX; Type 0: Not a Combination Product	11/06/2020
16	NDC: 79795-004-16	1200 in 1 BOX; Type 0: Not a Combination Product	11/06/2020

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

Labeler - NanTong Guarder Medical Technology Co.,Ltd. (554537961)

Registrant - NanTong Guarder Medical Technology Co.,Ltd. (554537961)

Establishment
Name	Address	ID/FEI	Business Operations
NanTong Guarder Medical Technology Co.,Ltd.		554537961	manufacture(79795-004)