Label at a glance#

ProductLeaders Mediu Soothing Aloe Pack

Active ingredientAllantoin

Label structure8 sections

Dosage and administration

Directions: After cleansing face, apply a thin layer of the Wash-Off Pack on the face, leaving out the area around eyes and mouth. Leave on for 5-10 minutes then wash off with tepid water. *Suggested use is 2-3 times a week

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Allantoin 0.50%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Glycerin, 1,2-Hexanediol, Butylene Glycol, Arginine, Carbomer, PEG-60 Hydrogenated Castor Oil , Aloe barbadensis Leaf Juice Powder, Sodium Polyacrylate, Portulaca Oleracea extract , Cucumis Sativus (Cucumber) Fruit extract, Fragrance, Buteth-3, Glyceryl Acrylate/Acrylic Acid Copolymer, Maltodextrin, PVM/MA Copolymer, Disodium EDTA, Sodium Benzotriazolyl Butylphenol Sulfonate, Tributyl Citrate, CI 19140, CI 42090, Sodium Hyaluronate

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Protectant

WARNINGS

WARNINGS SECTION

Warnings: For external use only. Avoid contact with eyes. Not for human consumption. Discontinue use if irritation occurs. If irritation persists, consult a physician.

Use immediately after opening. Store in cool and dry place. Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Directions

INDICATIONS & USAGE SECTION

Directions: After cleansing face, apply a thin layer of the Wash-Off Pack on the face, leaving out the area around eyes and mouth. Leave on for 5-10 minutes then wash off with tepid water. *Suggested use is 2-3 times a week

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: After cleansing face, apply a thin layer of the Wash-Off Pack on the face, leaving out the area around eyes and mouth. Leave on for 5-10 minutes then wash off with tepid water. *Suggested use is 2-3 times a week

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cello pack

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	8809242197194	GTIN-13: 8809242197194 EAN-13: 8809242197194 GTIN storage (14 digits): 08809242197194	leaders mediu soothing aloe pack cello pack.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69424-530-01	2020-01-31	C162847	48780-1	9d75b9d0-acae-f424-e053-dadaa90a57ce	3dc0a378-57d8-41c0-be38-06503a3d4270

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

Leaders Mediu Soothing Aloe Pack
Allantoin
Water
Glycerin

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69424-530	69424-530-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Allantoin	344S277G0Z	ACTIB
Water	059QF0KO0R	IACT
Glycerin	PDC6A3C0OX	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
94d496de-510c-4eda-b01a-0d824db9267d			3dc0a378-57d8-41c0-be38-06503a3d4270	2016-02-01	Warnings	Exact identifier spl id: 94d496de-510c-4eda-b01a-0d824db9267d spl set id: 3dc0a378-57d8-41c0-be38-06503a3d4270

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.