Clotrimazole 1%

Clotrimazole 1%
SPL v1
SPL
SPL Set ID 55fc471c-e80c-47a0-a148-968e0b3c85ab
Route
TOPICAL
Published
Effective Date 2014-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Water Carthamus Tinctorius Flower Oil Emu Oil Eucalyptus Globulus Whole Soybean Oil Lavender Oil Tea Tree Oil Peppermint Oil Olea Europaea Fruit Volatile Oil Almond Oil Rosa Canina Flower Oil Jojoba Oil Urea Butylated Hydroxytoluene .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-05-05

Description

For external use only Ask a doctor before use on children under 2 years of age When using this product avoid contact with eyes Stop use and ask doctor if irritation occurs, there is no improvement within 4 weeks (2 weeks for jock itch) If swallowed, get medical help or contact a poison control center immediately

Purpose

Anti-fungal


Medication Information

Purpose

Anti-fungal

Description

For external use only Ask a doctor before use on children under 2 years of age When using this product avoid contact with eyes Stop use and ask doctor if irritation occurs, there is no improvement within 4 weeks (2 weeks for jock itch) If swallowed, get medical help or contact a poison control center immediately

Section 50565-1

Keep out of reach of children

Section 51945-4

Warnings

For external use only

Ask a doctor before use on children under 2 years of age

When using this product avoid contact with eyes

Stop use and ask doctor if irritation occurs, there is no improvement within 4 weeks (2 weeks for jock itch)

If swallowed, get medical help or contact a poison control center immediately

Directions

Read all package directions and warnings before using:

Use only as directed

Clean the affected area with soap and warm water and dry throughly

Apply a thin layer over the affected area twice daily (morning and night) or as directed by a doctor

This product is not effective on the scalp or nails

Avoid applying to severly cracked or irritated areas

For athlete's foot pay special attention to spaces between toes, wear well-fitting vetilated 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 daily for 2 weeks

Supervise children in the use of this product

Intended foruse by normally healthy adults only

Persons under 18 years of age or thoes with sensitive or allergic skin should use only as directed by a doctor.

Active Ingredient

Clotrimazole 1%

Other Information

Apply to skin around affected areas. While not allfinger and toe fungal infections are curabel with OTC topical medications. If you see improvement whithin 4 weeks of use, you may continue to use until satisfactory results are obtained.

Inactive Ingredients

Aqua, BHT, safflower oil, emu oil, eucalyptus globlus oil, soybean oil, lavender oil, tea tree oil, peppermint oil, olive fruit oil, sweet almond oil, rose hip oil, jojoba oil, vitamin E, urea


Structured Label Content

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51945-4 (51945-4)

Purpose

Anti-fungal

Warnings

For external use only

Ask a doctor before use on children under 2 years of age

When using this product avoid contact with eyes

Stop use and ask doctor if irritation occurs, there is no improvement within 4 weeks (2 weeks for jock itch)

If swallowed, get medical help or contact a poison control center immediately

Directions

Read all package directions and warnings before using:

Use only as directed

Clean the affected area with soap and warm water and dry throughly

Apply a thin layer over the affected area twice daily (morning and night) or as directed by a doctor

This product is not effective on the scalp or nails

Avoid applying to severly cracked or irritated areas

For athlete's foot pay special attention to spaces between toes, wear well-fitting vetilated 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 daily for 2 weeks

Supervise children in the use of this product

Intended foruse by normally healthy adults only

Persons under 18 years of age or thoes with sensitive or allergic skin should use only as directed by a doctor.

Active Ingredient (Active ingredient)

Clotrimazole 1%

Other Information (Other information)

Apply to skin around affected areas. While not allfinger and toe fungal infections are curabel with OTC topical medications. If you see improvement whithin 4 weeks of use, you may continue to use until satisfactory results are obtained.

Inactive Ingredients (Inactive ingredients)

Aqua, BHT, safflower oil, emu oil, eucalyptus globlus oil, soybean oil, lavender oil, tea tree oil, peppermint oil, olive fruit oil, sweet almond oil, rose hip oil, jojoba oil, vitamin E, urea


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Raw Label Data

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