SPL v2
SPL
SPL Set ID c95feeb0-29ed-40a6-9afc-92e0ae3604d1
Route
TOPICAL
Published
Effective Date 2025-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Water Glycerin Cetostearyl Alcohol Glyceryl Monostearate Aloe Vera Leaf Juice Calendula Officinalis Flower Lavender Oil Coconut Oil Propolis Wax Thymol Allantoin Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-14

Description

Active ingredient: Clotrimazole 1%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Uses:

  • Temporarily protects minor cuts, scrapes, and burns.
  • Helps relieve and promote healing of chapped, chafed, or cracked skin.
Dosage and Administration

Directions

  • Cleanse and dry the affected area.
  • Apply a thin layer over the affected area twice daily (morning and evening).
  • Wash hands after each use.
  • Children under 12 years: ask a doctor.
Description

Active ingredient: Clotrimazole 1%

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 4 weeks
  • irritation, severe burning, or allergic reaction occurs
Section 50567-7

When using this product

  • a mild cooling, tingling, or numbing sensation may occur. This is temporary and generally harmless.
Section 50570-1

Do not use:

  • In the eyes, mouth, or vagina
  • for diaper rash
Section 51727-6

Inactive Ingredients

  • Purified Water
  • Glycerin
  • Cetearyl Alcohol
  • Glyceryl Stearate
  • Aloe Barbadensis Leaf Juice
  • Calendula Officinalis Flower Extract
  • Lavandula Angustifolia (Lavender) Oil
  • Cocos Nucifera (Coconut) Oil
  • Propolis Extract
  • Thymol
  • Allantoin
  • Tocopherol
Section 53413-1

Questions or comments?

Contact us at [email protected]

Section 55105-1
  • Antifungal
Section 55106-9

Active ingredient:

  • Clotrimazole 1%
Package Label.principal Display Panel


Structured Label Content

Indications and Usage (34067-9)

Uses:

  • Temporarily protects minor cuts, scrapes, and burns.
  • Helps relieve and promote healing of chapped, chafed, or cracked skin.
Dosage and Administration (34068-7)

Directions

  • Cleanse and dry the affected area.
  • Apply a thin layer over the affected area twice daily (morning and evening).
  • Wash hands after each use.
  • Children under 12 years: ask a doctor.
Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 4 weeks
  • irritation, severe burning, or allergic reaction occurs
Section 50567-7 (50567-7)

When using this product

  • a mild cooling, tingling, or numbing sensation may occur. This is temporary and generally harmless.
Section 50570-1 (50570-1)

Do not use:

  • In the eyes, mouth, or vagina
  • for diaper rash
Section 51727-6 (51727-6)

Inactive Ingredients

  • Purified Water
  • Glycerin
  • Cetearyl Alcohol
  • Glyceryl Stearate
  • Aloe Barbadensis Leaf Juice
  • Calendula Officinalis Flower Extract
  • Lavandula Angustifolia (Lavender) Oil
  • Cocos Nucifera (Coconut) Oil
  • Propolis Extract
  • Thymol
  • Allantoin
  • Tocopherol
Section 53413-1 (53413-1)

Questions or comments?

Contact us at [email protected]

Section 55105-1 (55105-1)
  • Antifungal
Section 55106-9 (55106-9)

Active ingredient:

  • Clotrimazole 1%
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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