BODY PRESCRIPTIONS FRENCH LAVENDER INFUSED WITH VITAMIN E ANTIBACTERIAL HAND- benzalkonium chloride lotion
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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50563-331/JAS21F12

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 palms 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, PEG 100 Stearate, Glycerin, C13-14 Isoparaffin, Laureth-7, Polyacrylamide, Phenoxyethanol, Benyl Alcohol, Fragrance (Parfum), Butyrospermum Parkii (Shea) Butter, Citric Acid, Tocopheryl Acetate, Red 33, Blue 1

image description

BODY PRESCRIPTIONS FRENCH LAVENDER INFUSED WITH VITAMIN E ANTIBACTERIAL HAND
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50563-331
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50563-331-01	236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/11/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/11/2020

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Name	Address	ID/FEI	Business Operations
Establishment
Xiamen Afgamarine Biotechnology Co., Ltd.		420485152	manufacture(50563-331)