ROYCEDERM COOLDEFENSE REFRESHING SHOWER GEL- tolnaftate 1.0% liquid

RoyceDerm CoolDefense Refreshing Shower Gel by

Drug Labeling and Warnings

RoyceDerm CoolDefense Refreshing Shower Gel by is a Otc medication manufactured, distributed, or labeled by RoyceDerm LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Tolnaftate 1.0%

PURPOSE

anti-fungal

INDICATIONS & USAGE

• Helps relieve and prevent athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
• Relieves itching, cracking, scaling, and discomfort caused by these fungal infections.

WARNINGS

For external use only

on children under 12 years of age.

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.

If pregnancy or breast feeding, ask a health professional before use.

Keep out of reach of Children. In case of accidental ingestion, seek medical advice immediately or contact a poison control center right away.

DOSAGE & ADMINISTRATION

• Apply a generous amount to wet skin.
• Massage gently to create a rich lather.
• Leave on for 1-2 minutes for maximum benefits.
• Rinse thoroughly with water.
• Use daily for best results.
• For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
• This product is not effective on the scalp or nails.

OTHER SAFETY INFORMATION

Store in a cool, dry place. Keep away from direct sunlight and heat sources.

INACTIVE INGREDIENT

Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Eucalyptus Globulus Leaf Oil, Menthol, Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Kernel Extract, Olea Europaea (Olive) Fruit Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate (Vitamin E), Citric Acid, Sodium Chloride, Phenoxyethanol, Ethylhexylglycerin

QUESTIONS

Email service@roycederm.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYCEDERM COOLDEFENSE REFRESHING SHOWER GEL 
tolnaftate 1.0% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85424-007
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 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
AQUA (UNII: 059QF0KO0R)
EUCALYPTUS GLOBULUS LEAF OIL (UNII: 2R04ONI662)
AVENA SATIVA (OAT) KERNEL OIL (UNII: 3UVP41R77R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MENTHOL (UNII: L7T10EIP3A)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85424-007-01	2 in 1 CARTON	08/31/2025
1		250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	08/31/2025

Labeler - RoyceDerm LLC (130329531)