FDA.reportPublic FDA data

Exemax Cream

Manufacturer
PureTek Corporation
Effective date
2025-07-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:06:20

Label at a glance#

ProductExemax Cream
Active ingredientALLANTOIN, DIMETHICONE
Label structure9 sections

Indications and uses

● temporarily protects and helps relieve chapped or cracked skin ● helps protect from the drying effects of wind and cold weather

Dosage and administration

● apply as needed

Storage and handling

● Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 5%
Allantoin 2%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

● temporarily protects and helps relieve chapped or cracked skin
● helps protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

● For external use only

When using this product

OTC - WHEN USING SECTION

● do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

● condition worsens

● symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

OTC - DO NOT USE SECTION

● deep or puncture wounds
● animal bites
● serious burns

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

● apply as needed

Other information

STORAGE AND HANDLING SECTION

● Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Avena sativa (Oat) Kernel Flour, Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus tinctorius (Safflower) Oleosomes, Centella Asiatica (Asiatic Pennywort) Extract, Citric Acid, DL-Alpha-Tocopheryl Acetate (Vitamin E), Ethylhexylglycerin, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Inositol, Lactic Acid, Maltodextrin, Niacinamide (Vitamin B3), Phenoxyethanol, Polyacrylate Crosspolymer-6, Pyridoxine HCl (Vitamin B6), Saccharide Isomerate, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Citrate, Sodium Hyaluronate, Sodium Hydroxide, Sodium Starch Octenylsuccinate, Tetrahexyldecyl Ascorbate, Zingiber Officinale (Ginger) Root Extract.

Exemax™ Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 877-921-7873

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2721109allantoin 2 % / dimethicone 5 % Topical CreamPSN1
2721109allantoin 20 MG/ML / dimethicone 50 MG/ML Topical CreamSCD1
2721109allantoin 2 % / dimethicone 5 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-212-07Exemax Cream85 g in 1 TUBECREAM851

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-212-07GM - Gram59088-2125beda155-3be9-4c95-9613-8727d7c42e7712025-08-11

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-21259088-212-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
HYALURONATE SODIUMYSE9PPT4THIACT
GINGERC5529G5JPQIACT
CITRIC ACID2968PHW8QPIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
OATZ6J799EAJKIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
CALCIUM PANTOTHENATE568ET80C3DIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
LACTIC ACID33X04XA5ATIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
NIACINAMIDE25X51I8RD4IACT
PYRIDOXINE HCL68Y4CF58BVIACT
SODIUM HYDROXIDE55X04QC32IIACT
ALLANTOIN344S277G0ZACTIB
MALTODEXTRIN7CVR7L4A2DIACT
POLYACRYLATE CROSSPOLYMER-6Q7UI015FF9IACT
SODIUM CITRATE1Q73Q2JULRIACT
DIMETHICONE92RU3N3Y1OACTIB
BISABOLOL24WE03BX2TIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
INOSITOL4L6452S749IACT
SACCHARIDE ISOMERATEW8K377W98IIACT

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
Exemax CreamDIMETHICONE, ALLANTOINPureTek Corporation38e79055-df84-d314-e063-6394a90ac95f2025-07-01WarningsExact identifier
ndc (package): 59088-212-07
ndc (product): 59088-212
ndc11 (package): 59088021207
spl id: 38e79055-df85-d314-e063-6394a90ac95f
spl set id: 38e79055-df84-d314-e063-6394a90ac95f

Reported adverse events (FAERS/openFDA)#

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