BODY PRESCRIPTIONS VITAMIN C TRAVEL PACK ANTIBACTERIAL HAND WIPES- benzalkonium chloride solution
ENCHANTE ACCESSORIES INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

G0ABCW02

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 over 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, Ascorbic Acid, Phenoxyethanol, Propylene Glycol, Fragrance

image description

BODY PRESCRIPTIONS VITAMIN C TRAVEL PACK ANTIBACTERIAL HAND WIPES
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50563-217
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50563-217-01	3 in 1 PACKAGE	06/12/2020
1		20 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/12/2020

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Ruolin Hygienic Products Co., Ltd.		415426870	manufacture(50563-217)