SPL v1
SPL
SPL Set ID a91d077f-8f9e-48fd-8554-0428bdfe1eb7
Route
TOPICAL
Published
Effective Date 2015-06-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Cetearyl Ethylhexanoate Dimethicone Edetate Disodium Glycerin Palmitic Acid Polysorbate 20 Propylene Glycol Povidones Stearic Acid .alpha.-tocopherol Acetate Trolamine Ubidecarenone Water

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-08-01

Description

SKIN HYDRATING TOPICAL FOAM CLO-1 ANTIFUNGAL FOAM Relief for itching and burning feet Helps support skin barrier function NET WT. 4.4 OZ (125g)

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

SKIN HYDRATING TOPICAL FOAM CLO-1 ANTIFUNGAL FOAM Relief for itching and burning feet Helps support skin barrier function NET WT. 4.4 OZ (125g)

Uses
  • For the treatment of most athlete's foot (tinea pedis) or ringworm (tinea corporis).
  • For effective relief of redness, irritation, scaling, cracking, itching, burning feet.
Section 50565-1

Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Section 50566-9

Stop use and ask a doctor if

• Irritation occurs or if there is no improvement wihin 4 weeks.

Section 50567-7

When using this product: • Avoid contact with the eyes.

• Do not use on deep or puncture wounds, infections or lacerations.

Section 50570-1

Do not use on children under 2 years of age unless directed by a doctor.

Section 53413-1

Questions or comments? Call toll free 1-855-317-1107

Warnings:

Directions
  • Hold can upright. Shake well before each application.
  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of the product over affected area 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 well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • For athlete's foot and ringworm, use daily for 4 weeks.
  • If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.
Active Ingredient

Clotrimazole 1%

Inactive Ingredients

Principal Display Panel  125g Can Label

SKIN HYDRATING

TOPICAL FOAM

CLO-1

ANTIFUNGAL FOAM

Relief for itching

and burning feet

Helps support

skin barrier function

NET WT. 4.4 OZ (125g)


Structured Label Content

Uses
  • For the treatment of most athlete's foot (tinea pedis) or ringworm (tinea corporis).
  • For effective relief of redness, irritation, scaling, cracking, itching, burning feet.
Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

• Irritation occurs or if there is no improvement wihin 4 weeks.

Section 50567-7 (50567-7)

When using this product: • Avoid contact with the eyes.

• Do not use on deep or puncture wounds, infections or lacerations.

Section 50570-1 (50570-1)

Do not use on children under 2 years of age unless directed by a doctor.

Section 53413-1 (53413-1)

Questions or comments? Call toll free 1-855-317-1107

Purpose

Antifungal

Warnings:

Directions
  • Hold can upright. Shake well before each application.
  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of the product over affected area 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 well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • For athlete's foot and ringworm, use daily for 4 weeks.
  • If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.
Active Ingredient

Clotrimazole 1%

Inactive Ingredients

Principal Display Panel  125g Can Label (PRINCIPAL DISPLAY PANEL - 125g Can Label)

SKIN HYDRATING

TOPICAL FOAM

CLO-1

ANTIFUNGAL FOAM

Relief for itching

and burning feet

Helps support

skin barrier function

NET WT. 4.4 OZ (125g)


Advanced Ingredient Data


Raw Label Data

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