FDA.reportPublic FDA data

BODY PRESCRIPTIONS INFUSED WITH VITAMIN E Sugar Cookie ANTIBACTERIAL HAND

Manufacturer
ENCHANTE ACCESSORIES INC. | Xiamen Afgamarine Biotechnology Co., Ltd.
Effective date
2021-07-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:16

Label at a glance#

ProductBODY PRESCRIPTIONS INFUSED WITH VITAMIN E Sugar Cookie ANTIBACTERIAL HAND
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Dosage and administration

Apply a small amount to palm and rub hands together thoroughly

Storage and handling

Do not store above 105F May doscolor some fabrics Harmful to wood finishes and plastics

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

■ To help reduce the bacteria on the skin

WARNINGS

WARNINGS SECTION

For external use only

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

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply a small amount to palm and rub hands together thoroughly

Other Information

STORAGE AND HANDLING SECTION

Do not store above 105F

May doscolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046442benzalkonium chloride 0.13 % Topical LotionPSN1
1046442benzalkonium chloride 1.3 MG/ML Topical LotionSCD1
1046442benzalkonium chloride 0.13 % Topical LotionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50563-466-012022-07-29C16284748780-1e4f33bdf-a604-d8a0-e053-dadaa90a6e4e50563-466/JAS21XL2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50563-466-01BODY PRESCRIPTIONS INFUSED WITH VITAMIN E Sugar Cookie ANTIBACTERIAL HAND236.6 mL in 1 BOTTLELOTION236.61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50563-466BODY PRESCRIPTIONS INFUSED WITH VITAMIN E SUGAR COOKIE ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LOTION [ENCHANTE ACCESSORIES INC.]1Legacy NDC, 1 package rows20210706_c8e5381c-bb0b-454a-8466-a19723a95196.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50563-46650563-466-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
PEG-100 STEARATEYD01N1999RIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
LAURETH-7Z95S6G8201IACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZYL ALCOHOLLKG8494WBHIACT
BENZOIC ACID8SKN0B0MIMIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES0C9AC7D6XUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FD&C RED NO. 4X3W0AM1JLXIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c658ae1a-e79d-4217-e053-2995a90ac065c8e5381c-bb0b-454a-8466-a19723a951962021-07-04WarningsExact identifier
spl id: c658ae1a-e79d-4217-e053-2995a90ac065
spl set id: c8e5381c-bb0b-454a-8466-a19723a95196