DERMAHEAL ULTIMATUM PTX SPORTS- allantoin gel

Dermaheal Ultimatum PTx Sports by

Drug Labeling and Warnings

Dermaheal Ultimatum PTx Sports by is a Otc medication manufactured, distributed, or labeled by Caregen Co.,Ltd., CAREGEN CO.,LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Allantoin 0.5%

INACTIVE INGREDIENT

Inactive ingredients:
Water (aqua), Alcohol, Cetearyl Alcohol, Caprylic/Capric Triglyceride, Sorbitan Stearate, Phenoxyethanol, Hexapeptide-46, 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

Purpose: External analgesic

WARNINGS

Warning:

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

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:

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

Directions

Directions:

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

INGREDIENTS AND APPEARANCE

DERMAHEAL ULTIMATUM PTX SPORTS 
allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60716-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.2 g  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60716-100-02	1 in 1 CARTON	07/01/2019
1	NDC: 60716-100-01	40 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/01/2019

Labeler - Caregen Co.,Ltd. (689850365)

Registrant - Caregen Co.,Ltd. (689850365)

Establishment
Name	Address	ID/FEI	Business Operations
Caregen Co.,Ltd.		689850365	manufacture(60716-100)