BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES BERRY TWIST- 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.

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G0ABCW13

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, Fragaria Chiloensis (Strawberry) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Phenoxyethanol, Propylene Glycol, Fragrance

image description

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES BERRY TWIST
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50563-245
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)
FRAGARIA CHILOENSIS WHOLE (UNII: R3Q9SDF6YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
RUBUS IDAEUS WHOLE (UNII: 7GOM628K2Z)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50563-245-01	3 in 1 PACKAGE	08/19/2020
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	08/19/2020

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Ruolin Hygienic Products Co., Ltd.		415426870	manufacture(50563-245)