SOFRESH DISINFECTING WIPES- benzalkonium chloride swab

Sofresh Disinfecting Wipes by

Drug Labeling and Warnings

Sofresh Disinfecting Wipes by is a Otc medication manufactured, distributed, or labeled by Zhejiang Huihao Daily Products Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

BENZALKONIUM CHLORIDE 0.13% 

Purpose

Antimicrobial

USES

• for hand sanitizing to decrease bacteria on skin
• safe for repeated use

Warning

• For external use only.
• When using this product, avoid contact with eyes. If in eyes, flush thoroughly with water

• Discontinue use and contact a doctor If irritation and redness develop and conditions persist for more than 72 hours

Other Information：

Store below 110℉ (43 ℃); May discolor certain fabrics or surface

●If swallowed, get medical help or contact a Poison Contrl Center right away.

Directions

• peel back label
• remove and unfold wipes
• wipe hards thoroughly for approximately 30 seconds
• dispose of used wipes in trash, do not flush

Inactive ingredients

Glycerin, Aloe vera, Vitamin E, Purified Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOFRESH DISINFECTING WIPES 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77909-002
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)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77909-002-01	50 in 1 BAG	05/18/2020
1		6 g in 1 POUCH; 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	05/18/2020

Labeler - Zhejiang Huihao Daily Products Co.,Ltd (541292810)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Huihao Daily Products Co.,Ltd		541292810	manufacture(77909-002)