BODY PRESCRIPTIONS SUGAR COOKIE INFUSED WITH VITAMIN E ANTIBACTERIAL FOAMING HAND- benzalkonium chloride soap

BODY PRESCRIPTIONS Sugar Cookie INFUSED WITH VITAMIN E ANTIBACTERIAL FOAMING HAND by

Drug Labeling and Warnings

BODY PRESCRIPTIONS Sugar Cookie INFUSED WITH VITAMIN E ANTIBACTERIAL FOAMING HAND by is a Otc medication manufactured, distributed, or labeled by ENCHANTE ACCESSORIES INC., Xiamen Afgamarine Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

■ For hand washing to decrease bacteria on the skin

WARNINGS

For external use only

When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Stop use and ask a doctor if skin irritation develops.

Keep out of reach of children. In case of accidenta ingestion, seek professional assistance or contact a Poison Control Center immdiately.

Directions

Apply a small amount to hands, lather for 20 seconds, then rinse with warm water.

Other Information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

Water, Cocamidopropyl Betaine, DMDM Hydantoin, Fragrance, Disodium EDTA, Citric Acid, Tocopheryl Acetate, Red 4, Yellow 5, Blue 1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BODY PRESCRIPTIONS SUGAR COOKIE INFUSED WITH VITAMIN E ANTIBACTERIAL FOAMING HAND 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50563-458
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 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DMDM HYDANTOIN (UNII: BYR0546TOW)
DISODIUM HEDTA (UNII: KME849MC7A)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-458-01	254 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/02/2021

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Afgamarine Biotechnology Co., Ltd.		420485152	manufacture(50563-458)