FDA.reportPublic FDA data

Dermaheal Ultimatum PTx Sports

Manufacturer
Caregen Co.,Ltd.
Effective date
2021-09-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:35:39

Label at a glance#

ProductDermaheal Ultimatum PTx Sports
Active ingredientAllantoin
Label structure8 sections

Indications and uses

Temporarily relieves the minor pains of muscles and joints associated with: simple backache, arthritis, and sprains.

Dosage and administration

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (aqua), Alcohol, Cetearyl Alcohol, Caprylic/Capric Triglyceride, Sorbitan Stearate, Phenoxyethanol, sh-Pentapeptide-12 SP, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, 1,2-Hexanediol, Caprylyl Glycol, Isohexadecane, Glyceryl Stearate, PEG-100 Stearate, Sodium Hyaluronate, Cocamide Methyl MEA, Glycerin, Xanthan Gum, Polysorbate 80, Aminopropyl Menthyl Phosphate, Sucrose Cocoate, Glycine Soja (Soybean) Oil, Hydrogenated Phosphatidylcholine, Sodium Oleate

PURPOSE

OTC - PURPOSE SECTION

External analgesic

WARNINGS

WARNINGS SECTION

For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. 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

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the minor pains of muscles and joints associated with: simple backache, arthritis, and sprains.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60716-100-022021-09-16C16284748780-1ab0e2407-2d66-f274-e053-dbdaa90a6471a46e148c-3f3f-4a47-aaeb-29a3ad02f54b
60716-100-022020-09-27C16284748780-1ab0e2407-2d66-f274-e053-dbdaa90a6471a46e148c-3f3f-4a47-aaeb-29a3ad02f54b
60716-100-022020-09-25C16284748780-1ab0e2407-2d66-f274-e053-dbdaa90a6471a46e148c-3f3f-4a47-aaeb-29a3ad02f54b
60716-100-022020-07-22C16284748780-1ab0e2407-2d66-f274-e053-dbdaa90a6471a46e148c-3f3f-4a47-aaeb-29a3ad02f54b

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60716-10060716-100-01, 60716-100-02

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
NameUNIIKind
Allantoin344S277G0ZACTIB
Water059QF0KO0RIACT
Alcohol3K9958V90MIACT

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
98b8603e-dc1a-4692-8894-312404c091caa46e148c-3f3f-4a47-aaeb-29a3ad02f54b2023-12-11WarningsExact identifier
spl set id: a46e148c-3f3f-4a47-aaeb-29a3ad02f54b

Reported adverse events (FAERS/openFDA)#

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