Molecular Af Molecular Cream

Molecular Af Molecular Cream
SPL v14
SPL
SPL Set ID 0fdc69e0-bb02-5de4-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2012-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (0.3 g)
Inactive Ingredients
Benzoic Acid Water Xanthan Gum Glycerin Cetostearyl Alcohol Polawax Polysorbate Trimethyl-1,3-pentanediol Tea Tree Oil Cinnamon Oil Ethyl Macadamiate Trolamine Phenoxyethanol Oregano Leaf Oil Polyoxyl 20 Cetostearyl Ether Propylene Glycol Olive Oil .alpha.-tocopherol Acetate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-03-31

Description

Miconazole Nitrate 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Dosage and Administration

Directions:

  • clean the affected area and dry thoroughly
  • apply a thin layer over the affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot, pay special attention to the spaces between toes..

    Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • use daily for 4 weeks. If condition lasts longer, as a doctor
  • to prevent athlete's foot, apply to the feet once or twice daily
  • this product is not effective on the scalp or nails
Description

Miconazole Nitrate 2%

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

  • irritation occurs
  • there is no improvement within 4 weeks
Section 51945-4

Warnings

For external use only

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

When using this product avoid contact with the eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement with 4 weeks

Directions

Directions:

  • clean the affected area and dry thoroughly
  • apply a thin layer over the affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot, pay special attention to the spaces between toes. Wear well-fitting, ventilated shoes, and

    change shoes and socks at least once daily.
  • use daily for 4 weeks. If condition lasts longer, ask a doctor
  • to prevent athlete's foot, apply to the feet once or twice daily
  • this product is not effective on the scalp or nails
Active Ingredient

Miconazole Nitrate 2%

Other Information

  • Store at 68° - 77º (20º - 25º C)
Inactive Ingredients

Cetearyl Alcohol, Ceteareth-20, Cinnamonum Verum Oil, Citric Acid, Deionized Water, Emulsifying Wax NF, Ethyl Macadamiate,

Glycerin (Veg.), Melaleuca Alternifolia Oil, Olea Europaea Oil, Origanum Vulgare Oil, Phenoxyethanol, Benzoic Acid,

Dehydroacetic Acid, Propylene Glycol, Trimethylpentanediol / Adipic Acid Copolymer, Vitamin E Acetate, Xanthan Gum

Box, Principal Display Panel


Structured Label Content

Dosage and Administration (34068-7)

Directions:

  • clean the affected area and dry thoroughly
  • apply a thin layer over the affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot, pay special attention to the spaces between toes..

    Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • use daily for 4 weeks. If condition lasts longer, as a doctor
  • to prevent athlete's foot, apply to the feet once or twice daily
  • this product is not effective on the scalp or nails
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

  • irritation occurs
  • there is no improvement within 4 weeks
Section 51945-4 (51945-4)

Purpose

Antifungal

Warnings

For external use only

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

When using this product avoid contact with the eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement with 4 weeks

Directions

Directions:

  • clean the affected area and dry thoroughly
  • apply a thin layer over the affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot, pay special attention to the spaces between toes. Wear well-fitting, ventilated shoes, and

    change shoes and socks at least once daily.
  • use daily for 4 weeks. If condition lasts longer, ask a doctor
  • to prevent athlete's foot, apply to the feet once or twice daily
  • this product is not effective on the scalp or nails
Active Ingredient

Miconazole Nitrate 2%

Other Information

  • Store at 68° - 77º (20º - 25º C)
Inactive Ingredients

Cetearyl Alcohol, Ceteareth-20, Cinnamonum Verum Oil, Citric Acid, Deionized Water, Emulsifying Wax NF, Ethyl Macadamiate,

Glycerin (Veg.), Melaleuca Alternifolia Oil, Olea Europaea Oil, Origanum Vulgare Oil, Phenoxyethanol, Benzoic Acid,

Dehydroacetic Acid, Propylene Glycol, Trimethylpentanediol / Adipic Acid Copolymer, Vitamin E Acetate, Xanthan Gum

Box, Principal Display Panel (BOX, Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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