ANTISEPTIC SANITIZING WIPES- benzalkonium chloride 0.13% cloth

ANTISEPTIC SANITIZING WIPES by

Drug Labeling and Warnings

ANTISEPTIC SANITIZING WIPES by is a Otc medication manufactured, distributed, or labeled by ZHEJIANG WIPEX NEW MATERIAL TECHNOLOGY CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ANTISEPTIC SANITIZING WIPES

ACTIVE INGREDIENT

Benzalkonium Chloride 0.13%

PURPOSE

For hand washing to decrease bacteria on skin

Recommended for repeated use.

INDICATIONS & USAGE

For hand washing to decrease bacteria on skin

Recommended for repeated use.

WARNINGS

For external use only

DO NOT USE

In the eyes

WHEN USING

Wet hands thoroughly with product andallaw to dry without wiping.

STOP USE

lrritation and redness develops
Condition persists for more than 72 hours

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If
swallowed, get medical help or contacta poison control center right away.

DOSAGE & ADMINISTRATION

Wet hands thoroughly with product andallow to dry without wiping.

STORAGE AND HANDLING

Store below 104F(40°C)
May discolor certain fabrics

INACTIVE INGREDIENT

water
Glycerin
Disodium Cocoamphodiacetate
Phenoxyethanol
Benzoic Acid
Polysorbate 20
Potassium Sorbate
Aloe barbadensia Leaf juice
Benzalkonium Chloride
Melaleuca Alternifolia (Tea Tree) Leaf Oil
Menthol
Sodium Citrate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTISEPTIC SANITIZING WIPES 
benzalkonium chloride 0.13% cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83666-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.013 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM CITRATE (UNII: 1Q73Q2JULR)
MENTHOL (UNII: L7T10EIP3A)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83666-001-01	900 g in 1 BAG; Type 0: Not a Combination Product	09/08/2023
2	NDC: 83666-001-02	10 g in 1 BAG; Type 0: Not a Combination Product	09/08/2023
3	NDC: 83666-001-03	1 g in 1 BAG; Type 0: Not a Combination Product	09/08/2023
4	NDC: 83666-001-04	15 g in 1 BAG; Type 0: Not a Combination Product	09/08/2023
5	NDC: 83666-001-05	50 g in 1 BAG; Type 0: Not a Combination Product	09/08/2023
6	NDC: 83666-001-06	20 g in 1 BAG; Type 0: Not a Combination Product	09/08/2023
7	NDC: 83666-001-07	100 g in 1 BAG; Type 0: Not a Combination Product	09/08/2023
8	NDC: 83666-001-08	1200 g in 1 BAG; Type 0: Not a Combination Product	09/08/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	09/07/2023

Labeler - ZHEJIANG WIPEX NEW MATERIAL TECHNOLOGY CO.,LTD (724693982)

Registrant - ZHEJIANG WIPEX NEW MATERIAL TECHNOLOGY CO.,LTD (724693982)

Establishment
Name	Address	ID/FEI	Business Operations
ZHEJIANG WIPEX NEW MATERIAL TECHNOLOGY CO.,LTD		724693982	manufacture(83666-001)