Initial Drug Listing - Roycederm Antifungal Bar

Initial Drug Listing - Roycederm Antifungal Bar
SPL v1
SPL
SPL Set ID 3abdc4a8-58dd-5bd0-e063-6294a90a1bca
Route
TOPICAL
Published
Effective Date 2025-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (2.32 g)
Inactive Ingredients
Butyrospermum Parkii (shea) Butter Sorbitol Stearic Acid Tallow Glycerin Propanediol Sucrose Cocamidopropyl Betaine Sodium Hydroxide Mentha Arvensis Leaf Oil Sodium Citrate Aloe Barbadensis Leaf Juice Sodium Laureth Sulfate Aqua Charcoal Powder Melaleuca Alternifolia (tea Tree) Leaf Oil Lauric Acid

Identifiers & Packaging

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

Description

Clotrimazole 1%


Medication Information

Warnings and Precautions

For externaluse only.

Indications and Usage
  • Wash affected area well, rinse after 2 minutes. Dry thoroughly.
  • Use twice daily (morning and night) or as directed by a doctor.
  • Supervise children in the use of this product.
  • For athlete's foot: Pay special attention to spaces between the toes; wear wellfitting, ventilated shoes, and change shoes and socks at least once daily.
  • For athlete's foot and ringworm, use daily for 4 weeks, for jock itch, use dailyfor 2 weeks. lf condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.
Dosage and Administration

Treats Athlete's foot (tinea pedis), Jock itch(tinea cruris),Ringworm (tinea corporis).-Relieves ltching, burning, cracking.

Description

Clotrimazole 1%

Section 50565-1

lf swallowed,call poison control or seek medical help.

Section 50567-7

avoid contact withthe eyes.

Section 50569-3

irritation occurs-there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.

Section 50570-1

on children under two years of age unless directed by a doctor.

Section 51727-6

Sorbitol, Sucrose, Stearic Acid, Tallow, Cocamidopropyl Betaine, Propanediol,Glycerin, Sodium Laureth Sulfate, Water (Aqua), Lauric Acid, Sodium Hydroxide,Sodium Citrate, Charcoal Powder, Volcanic Ash, Melaleuca Alternifolia (Tea Tree)Leaf Oil, Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea) Butter,Mentha Arvensis Leaf Oil

Section 51945-4

Section 55105-1

Anti-fungal

Section 55106-9

Clotrimazole 1%

Section 60561-8

store at room temperature and keep away from direct sunlight.


Structured Label Content

Indications and Usage (34067-9)
  • Wash affected area well, rinse after 2 minutes. Dry thoroughly.
  • Use twice daily (morning and night) or as directed by a doctor.
  • Supervise children in the use of this product.
  • For athlete's foot: Pay special attention to spaces between the toes; wear wellfitting, ventilated shoes, and change shoes and socks at least once daily.
  • For athlete's foot and ringworm, use daily for 4 weeks, for jock itch, use dailyfor 2 weeks. lf condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.
Dosage and Administration (34068-7)

Treats Athlete's foot (tinea pedis), Jock itch(tinea cruris),Ringworm (tinea corporis).-Relieves ltching, burning, cracking.

Warnings and Precautions (34071-1)

For externaluse only.

Section 50565-1 (50565-1)

lf swallowed,call poison control or seek medical help.

Section 50567-7 (50567-7)

avoid contact withthe eyes.

Section 50569-3 (50569-3)

irritation occurs-there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.

Section 50570-1 (50570-1)

on children under two years of age unless directed by a doctor.

Section 51727-6 (51727-6)

Sorbitol, Sucrose, Stearic Acid, Tallow, Cocamidopropyl Betaine, Propanediol,Glycerin, Sodium Laureth Sulfate, Water (Aqua), Lauric Acid, Sodium Hydroxide,Sodium Citrate, Charcoal Powder, Volcanic Ash, Melaleuca Alternifolia (Tea Tree)Leaf Oil, Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea) Butter,Mentha Arvensis Leaf Oil

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anti-fungal

Section 55106-9 (55106-9)

Clotrimazole 1%

Section 60561-8 (60561-8)

store at room temperature and keep away from direct sunlight.


Advanced Ingredient Data


Raw Label Data

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