Initial Drug Listing - Roycederm Cooldefense & Refreshing Shower Gel

Initial Drug Listing - Roycederm Cooldefense & Refreshing Shower Gel
SPL v1
SPL
SPL Set ID 3b3216d6-8cc8-ea89-e063-6294a90ab691
Route
TOPICAL
Published
Effective Date 2025-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Aloe Barbadensis Leaf Juice Aqua Eucalyptus Globulus Leaf Oil Avena Sativa (oat) Kernel Oil Cocamidopropyl Betaine Sodium Laureth Sulfate Phenoxyethanol Citric Acid Glycerin Olea Europaea (olive) Fruit Oil Sodium Chloride Menthol Ethylhexylglycerin .alpha.-tocopherol Acetate Melaleuca Alternifolia (tea Tree) Leaf Oil Simmondsia Chinensis (jojoba) Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-31
Description

Tolnaftate 1.0%

Medication Information

Warnings and Precautions

For external use only

Indications and 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.

Dosage and 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.
Description

Tolnaftate 1.0%

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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

Section 50570-1

on children under 12 years of age.

Section 51727-6

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

Section 51945-4

Section 53413-1

Email [email protected]

Section 53414-9

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

Section 55105-1

anti-fungal

Section 55106-9

Tolnaftate 1.0%

Section 60561-8

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

Structured Label Content

Indications and Usage (34067-9)
  • 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.

Dosage and Administration (34068-7)
  • 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.
Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

on children under 12 years of age.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Email [email protected]

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

anti-fungal

Section 55106-9 (55106-9)

Tolnaftate 1.0%

Section 60561-8 (60561-8)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:53.062979 · Updated: 2026-03-14T23:09:55.704959