PHYTOZINE RINGWORM TREATMENT MAXIMUM STRENGTH- tolnaftate ointment

PHYTOZINE RINGWORM TREATMENT by

Drug Labeling and Warnings

PHYTOZINE RINGWORM TREATMENT by is a Otc medication manufactured, distributed, or labeled by The Sisquoc Healthcare Corporation, COASTAL CONTRACT PACKAGING, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

TOLNAFTATE 1%

PURPOSE

ANTIFUNGAL

USES

• CURES MOST RINGWORM
• RELIEVES ITCHING, REDNESS, IRRITATION AND DISCOMFORT WHICH ACCOMPANY THIS CONDITION.

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT AVOID CONTACT WITH THE EYES.

STOP USE AND ASK A DOCTOR IF

• IRRITATION OCCURS
• THERE IS NO IMPROVEMENT WITHIN 4 WEEKS.

DO NOT USE ON CHILDREN UNDER 2 YEARS OF AGE UNLESS DIRECTED BY A DOCTOR.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• For the cure of most ringworm (tinea corporis) and athlete’s foot (tinea pedis). For relief of itching, scaling, cracking, burning, redness, soreness, irritation and discomforts which may accompany these conditions.
• Wash affected area and dry thoroughly. Apply a layer of PHYTOZINE over the affected area twice daily (morning and night). Allow the cream to dry for at least 3 minutes before covering the affectedarea with clothing.
• Wash hands after each application to preventthe chance of the infection spreading to other parts of the skin.
• Most ringworm infections will require between 3-4 weeks of continuous daily treatment before the infection is completely eliminated.
• Proper use of PHYTOZINE will eliminate most ringworm infections. If the condition persists longer, contact a physician or medical professional.

INACTIVE INGREDIENTS

Water, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Polysorbate-20, Sodium Polyacrylate, Hydrogenated Polydecene, Trideceth-6, Glyceryl Stearate, PEG-100, Stearate, Propylene Glycol, Cetyl Alcohol, Oleth-10 Phosphate, Glycerin, Avena (Oat), Kernel Extract, Aloe Barbadensis Leaf Juice, Actrostaphylos Uva Ursi Leaf Extract, Propolis Extract, Theobroma Cacao
(Cocoa) Seed Butter, Rosa Canina Fruit Oil, Camphor, Menthol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula
Angustifolia (Lavender) Oil, Jasminum Of􀏐icinale (Jasmine) Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Tocopheryl
Acetate, Stearic Acid, Propylene Glycol, Butylene Glycol, Cetyl Hydroxyethylcellulose, Sodium Hydroxide, Phenoxyethanol , Ethylhexylglycerin

OTHER SAFETY INFORMATION

Store between 20°c to 25°C (68° to 77°F)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PHYTOZINE RINGWORM TREATMENT  MAXIMUM STRENGTH
tolnaftate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71229-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALMOND OIL (UNII: 66YXD4DKO9)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETYL ALCOHOL (UNII: 936JST6JCN)
OLETH-10 PHOSPHATE (UNII: Q95361F4VS)
GLYCERIN (UNII: PDC6A3C0OX)
OAT (UNII: Z6J799EAJK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
MENTHOL (UNII: L7T10EIP3A)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)
JASMINUM OFFICINALE WHOLE (UNII: X3314B4SYD)
CLOVE LEAF OIL (UNII: VCA5491KVF)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
STEARIC ACID (UNII: 4ELV7Z65AP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71229-101-11	28 g in 1 TUBE; Type 0: Not a Combination Product	03/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	03/25/2019

Labeler - The Sisquoc Healthcare Corporation (021517142)

Establishment
Name	Address	ID/FEI	Business Operations
COASTAL CONTRACT PACKAGING, INC.		137341611	manufacture(71229-101)