ANTISEPTIC TOWELETTE 01- benzalkonium chloride cloth

antiseptic towelette by

Drug Labeling and Warnings

antiseptic towelette by is a Otc medication manufactured, distributed, or labeled by Cosmuses Cosmetics (Ningbo) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Fact

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

First Aid Antiseptic

Uses

antiseptic cleansig of face, hands and body to decrease bacteria on skin without soap and water.

Warning

For external use only.

Do not use in the eyes. If this happens, rinse thoroughly with water.

Stop use and ask a doctor if irritation or redness develop and persists for more than 72 hours.

Keep out of reach of children if swallowed, get medical help or contact a poison control center right away.

Directions

Tear open packet, unfold and use as a washcloth. Allow hand to dry without wiping.

Inactive Ingredients

Aqua, Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Extract, Phenoxyethanol, Tocopheryl Acetate, Polysorbate 20, Fragrance, Ethylhexylglycerin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTISEPTIC TOWELETTE  01
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82953-004
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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82953-004-01	10 in 1 BAG; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	10/13/2022
2	NDC: 82953-004-02	15 in 1 BAG; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	10/13/2022
3	NDC: 82953-004-03	20 in 1 BAG; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	10/13/2022
4	NDC: 82953-004-04	30 in 1 BAG; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	10/13/2022
5	NDC: 82953-004-05	50 in 1 BAG; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	10/13/2022
6	NDC: 82953-004-06	100 in 1 BAG; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	10/13/2022
7	NDC: 82953-004-07	1 in 1 BAG; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	10/13/2022
8	NDC: 82953-004-08	10 in 1 JAR; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	10/13/2022
9	NDC: 82953-004-09	20 in 1 JAR; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	10/13/2022
10	NDC: 82953-004-10	30 in 1 JAR; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	10/13/2022
11	NDC: 82953-004-11	50 in 1 JAR; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	10/13/2022
12	NDC: 82953-004-12	60 in 1 JAR; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	10/13/2022
13	NDC: 82953-004-13	100 in 1 JAR; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	10/13/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/01/2022

Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmuses Cosmetics (Ningbo) Co., Ltd.		725290934	manufacture(82953-004)