ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth

Antibacterial Hand Wipes by

Drug Labeling and Warnings

Antibacterial Hand Wipes by is a Otc medication manufactured, distributed, or labeled by Skaffles Group Limited Liability Company, Dalian Da Xin Nonwoven Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

USE

For external use only .

For hand washing to decrease bacteria on the skin.
Recommended for repeated use.

Warning

For external use only.

Do not use
If you are allergic to any of the ingredients. In the eyes; if contact occurs, rinse thoroughly with water.
Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

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

Directions

Directions● Adults and children 2 yrs and over,
apply to hands and allow skin to dry without wiping.
●Children under 2, ask doctor before use.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Cetylpyridinium Chloride, Chamomilla Recutita(Matricaria)Flower Extract, Citric Acid, Disodium Cocoamphodiacetate, Disodium EDTA, PEG-75 Lanolin,PEG-8Dimethicone,Phenoxyethanol,Potassium Sorbate, Quatermium-52, Sodium Benzoate, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77720-019
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)
QUATERNIUM-52 (UNII: 588EQF3H1P)
PEG-75 LANOLIN (UNII: 09179OX7TB)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
CHAMOMILE (UNII: FGL3685T2X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77720-019-01	1 in 1 BAG	01/15/2021
1		2.7 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
2	NDC: 77720-019-02	15 in 1 POUCH	01/15/2021
2		40.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
3	NDC: 77720-019-03	20 in 1 POUCH	01/15/2021
3		54 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
4	NDC: 77720-019-04	25 in 1 POUCH	01/15/2021
4		67.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
5	NDC: 77720-019-05	30 in 1 POUCH	01/15/2021
5		81 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
6	NDC: 77720-019-06	50 in 1 POUCH	01/15/2021
6		135 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
7	NDC: 77720-019-07	75 in 1 POUCH	01/15/2021
7		202.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
8	NDC: 77720-019-08	100 in 1 POUCH	01/15/2021
8		270 g in 1 NOT APPLICABLE; 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	01/15/2021

Labeler - Skaffles Group Limited Liability Company (831115642)

Establishment
Name	Address	ID/FEI	Business Operations
Dalian Da Xin Nonwoven Technology Co., Ltd.		415363991	manufacture(77720-019)