BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES WINTER MINT- benzalkonium chloride solution

BODY PRESCRIPTIONS ANTIBACTERIAL Hand Wipes WINTER MINT by

Drug Labeling and Warnings

BODY PRESCRIPTIONS ANTIBACTERIAL Hand Wipes WINTER MINT 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

When using this product, avoid contact with eyes. In case of contact with eyes, rinse eyes thoroughly with water

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

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

Aloe Barbadensis Leaf Extract, Ethylhexylglycerin, Fragrance, Glycerin, Mentha Arvensis Leaf Extract, Phenoxyethanol, Propylene Glycol, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES WINTER MINT 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50563-367
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	3.6 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-367-01	100 in 1 PACKET; Type 0: Not a Combination Product	10/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/20/2020

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ruolin Hygienic Products Co., Ltd.		415426870	manufacture(50563-367)