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

BODY PRESCRIPTIONS INFUSED WITH VITAMIN E Sugar Cookie ANTIBACTERIAL HAND by

Drug Labeling and Warnings

BODY PRESCRIPTIONS INFUSED WITH VITAMIN E Sugar Cookie ANTIBACTERIAL 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

■ To help reduce the 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 palm and rub hands together thoroughly

Other Information

Do not store above 105F

May doscolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

Water, Cetearyl Alcohol, Mineral Oil, Glyceryl Stearate, Glycerin, PEG-100 Stearate,  C13-14 Isoparaffin, Polyacrylamide, Laureth-7, Phenoxyethanol, Benzyl Alcohol, Benzoic Acid, Fragrance (Parfum), Citric Acid, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Red 4, Yellow 5, Blue 1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50563-466
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
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
LAURETH-7 (UNII: Z95S6G8201)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-466-01	236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/04/2021

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Afgamarine Biotechnology Co., Ltd.		420485152	manufacture(50563-466)