BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES COCONUT VANILLA- benzalkonium chloride solution

BODY PRESCRIPTIONS Antibacterial Hand Wipes Coconut Vanilla by

Drug Labeling and Warnings

BODY PRESCRIPTIONS Antibacterial Hand Wipes Coconut Vanilla by is a Otc medication manufactured, distributed, or labeled by ENCHANTE ACCESSORIES INC., Zhejiang Ruolin Hygienic Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Use

■ To decrease bacteria on hands

WARNINGS

For external use only

Stop Use

Do not use if you are allergic to any ingredients listed

Discontinue use if irritation or redness occur. Consult a doctor if condition lasts for more than 72 hours

Do not get into eyes. Rinse thoroughly with water if contact occurs

keep out of reach of children

Keep out of reach of children

Directions

For adults and children two years and over

Peel back reusable label and remove a wipe from the packet.

Wet hands thoroughly and air dry. 

Place used wipes in to waste basket.  Do not flush.

Inactive ingredients

Water, Glycerin, Ethylhexylglycerin, Vanilla Planifolia Fruit Extract, Cocos Nucifera (Coconut) Oil, Phenoxyethanol, Propylene Glycol, Fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES COCONUT VANILLA 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50563-243
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	4.5 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
VANILLA PLANIFOLIA FLOWER (UNII: 33NF0M2062)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCONUT OIL (UNII: Q9L0O73W7L)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-243-01	3 in 1 PACKAGE	08/19/2020
1		20 in 1 PACKET; 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	08/19/2020

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ruolin Hygienic Products Co., Ltd.		415426870	manufacture(50563-243)