Ndc更新 - 85424-004

Ndc更新 - 85424-004
SPL v4
SPL
SPL Set ID 3a6d1e32-a38b-3dde-e063-6394a90a88f3
Route
TOPICAL
Published
Effective Date 2026-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (2.32 g)
Inactive Ingredients
Coconut Oil Stearic Acid Sodium Glutamate Sodium Dodecylbenzenesulfonate Glycerin Sodium Hydroxide Aqua Witch Hazel Myristic Acid Propylene Glycol Sodium Myristoyl Glutamate Sodium Myristate Melaleuca Alternifolia (tea Tree) Leaf Oil Olea Europaea (olive) Fruit Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2025-08-06 Until 2026-02-01

Description

Clotrimazole 1%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage
  • For effective treatment of most athlete's foot(tinea pedis), ringworm (tinea corporis) and jock itch(tinea cruris).
  • For effective relief of itching, burning and cracking skin.
Dosage and Administration
  • Clean the affected area and dry thoroughly.product over the affected area twice daily (morning and night) doctor.
  • Supervise children in the use of this product.
  • For attention to spaces between the toes; wear well-fitting, ventshoes and socks at least once daily.
  • For athlete's foot and rweeks.
  • For jock itch, use daily for 2 weeks.
  • If condition pdoctor.
  • This product is not effective on the scalp or nails.
Description

Clotrimazole 1%

Section 50565-1

If swallowed, get medical help or contact aPoison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

irritationoccurs, there is no improvement within 4 weeks forathlete's foot or ringworm, there is no improvementwithin 2 weeks for jock itch.

Section 50567-7

When using this product

avoid contact withthe eyes.

Section 50570-1

on children under 2 years of age unless directed by adoctor.

Section 51727-6

Sodium Myristoyl Glutamate, Sodium Hydroxide, Sorbitol, Glycerin, Water, Propylene Glycol, Sodium Dodecylbenzenesulfonate, Cocos Nucifera (Coconut) OIl, Elaels Guineensis(Palm) Oil, Hamamelis Virginiana (Witch Hazel) Extract, Olea Europaea (Olive) Fruit Oil,Ceramide NP, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Stearic Acid, Lauric Acid, Myristic Acid

Section 51945-4

Section 53413-1

visit www.roycederm.com

Section 55105-1

Anti-fungal

Section 55106-9

Clotrimazole 1%

Section 60561-8
  • Store at room temperature
  • Avoid excessive heat and direct sunlight.

Structured Label Content

Indications and Usage (34067-9)
  • For effective treatment of most athlete's foot(tinea pedis), ringworm (tinea corporis) and jock itch(tinea cruris).
  • For effective relief of itching, burning and cracking skin.
Dosage and Administration (34068-7)
  • Clean the affected area and dry thoroughly.product over the affected area twice daily (morning and night) doctor.
  • Supervise children in the use of this product.
  • For attention to spaces between the toes; wear well-fitting, ventshoes and socks at least once daily.
  • For athlete's foot and rweeks.
  • For jock itch, use daily for 2 weeks.
  • If condition pdoctor.
  • This product is not effective on the scalp or nails.
Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact aPoison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

irritationoccurs, there is no improvement within 4 weeks forathlete's foot or ringworm, there is no improvementwithin 2 weeks for jock itch.

Section 50567-7 (50567-7)

When using this product

avoid contact withthe eyes.

Section 50570-1 (50570-1)

on children under 2 years of age unless directed by adoctor.

Section 51727-6 (51727-6)

Sodium Myristoyl Glutamate, Sodium Hydroxide, Sorbitol, Glycerin, Water, Propylene Glycol, Sodium Dodecylbenzenesulfonate, Cocos Nucifera (Coconut) OIl, Elaels Guineensis(Palm) Oil, Hamamelis Virginiana (Witch Hazel) Extract, Olea Europaea (Olive) Fruit Oil,Ceramide NP, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Stearic Acid, Lauric Acid, Myristic Acid

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

visit www.roycederm.com

Section 55105-1 (55105-1)

Anti-fungal

Section 55106-9 (55106-9)

Clotrimazole 1%

Section 60561-8 (60561-8)
  • Store at room temperature
  • Avoid excessive heat and direct sunlight.

Advanced Ingredient Data


Raw Label Data

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