Simply Vital Antifungal Cream

Simply Vital Antifungal Cream
SPL v2
SPL
SPL Set ID d3842de3-0d13-4dc2-920b-90a4b822bbb8
Route
TOPICAL
Published
Effective Date 2022-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Aloe Vera Leaf Water Cetostearyl Alcohol Cetyl Stearate Ethylhexyl Palmitate Ethylhexylglycerin Glycerin Hamamelis Virginiana Root Bark/stem Bark Tea Tree Oil Phenoxyethanol Polysorbate 20 Propylene Glycol Sorbitan Monostearate Thyme .alpha.-tocopherol Acetate Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-25

Description

Clotrimazole 1.00%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Clotrimazole 1.00%

Uses:
  • proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm.
  • for effective relief of itching, scaling, burning, soreness, irritation and discomfort.
Warnings:

For external use only.

Do Not Use

on children under 2 years of age unless directed by a doctor 

Drug Facts

Questions?

+1 (205) 624-9177

Directions:
  • 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; weat well-fitting, 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 daily for 2 weeks.
  • if condition persists longer, consult a doctor.
  • this product is not effective on the scalp or nails. 
Active Ingredient

Clotrimazole 1.00%

Package Labeling:

Other Information:
  • protect the product in this container from excessive heat and direct sun.
Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetearyl Alcohol, Cetyl Stearate, Ethylhexyl Palmitate, Ethylhexylglycerin, Glycerin, Hamamelis Virginiana (Witch Hazel), Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Sorbitan Stearate, Thymus Vulgaris (Thyme) Extract, Tocopheryl Acetate (Vitamin E), Triethanolamine.

When Using This Product
  • avoid contact with the eyes
  • irritation occurs.
  • condition persists.
  • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

Discontinue use and ask a doctor if

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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


Structured Label Content

Uses:
  • proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm.
  • for effective relief of itching, scaling, burning, soreness, irritation and discomfort.
Purpose

Antifungal

Warnings:

For external use only.

Do Not Use (Do not use)

on children under 2 years of age unless directed by a doctor 

Drug Facts

Questions?

+1 (205) 624-9177

Directions:
  • 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; weat well-fitting, 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 daily for 2 weeks.
  • if condition persists longer, consult a doctor.
  • this product is not effective on the scalp or nails. 
Active Ingredient (Active ingredient)

Clotrimazole 1.00%

Package Labeling:

Other Information: (Other information:)
  • protect the product in this container from excessive heat and direct sun.
Inactive Ingredients: (Inactive ingredients:)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetearyl Alcohol, Cetyl Stearate, Ethylhexyl Palmitate, Ethylhexylglycerin, Glycerin, Hamamelis Virginiana (Witch Hazel), Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Sorbitan Stearate, Thymus Vulgaris (Thyme) Extract, Tocopheryl Acetate (Vitamin E), Triethanolamine.

When Using This Product (When using this product)
  • avoid contact with the eyes
  • irritation occurs.
  • condition persists.
  • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

Discontinue use and ask a doctor if

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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