Label: DYNAREX ANTIFUNGAL- antifungal cream
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NDC Code(s):
67777-231-01,
67777-231-02,
67777-231-10,
67777-231-11, view more67777-231-12, 67777-231-13
- Packager: Dynarex Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 20, 2024
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- Official Label (Printer Friendly)
- Active Ingredient
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Purpose
- For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
- For the treatment of superficial skin infections caused by Yeast (Candida Albicans).
- Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch.
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Warnings
Do not use:
- Do not use on children under 2 years of age unless directed by a doctor.
- Avoid contact with eyes.
- For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
- For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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Indications and Usage
- Clean the affected area and dry thoroughly. Apply a layer of cream 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 toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
- Dosage and Administration
- Keep Out Of Reach Of Children
- INACTIVE INGREDIENTS
- Label
- Label
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INGREDIENTS AND APPEARANCE
DYNAREX ANTIFUNGAL
antifungal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-231 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 g in 100 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) CETETH-20 (UNII: I835H2IHHX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LIGHT MINERAL OIL (UNII: N6K5787QVP) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67777-231-13 72 in 1 CASE 05/18/2010 1 NDC:67777-231-12 1 in 1 BOX 1 NDC:67777-231-02 28.25 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:67777-231-11 24 in 1 CASE 05/18/2010 2 NDC:67777-231-10 6 in 1 BOX 2 NDC:67777-231-01 113 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 05/18/2010 Labeler - Dynarex Corporation (008124539) Registrant - Dynarex Corporation (008124539)