Clotrimazole description, usages, side effects, indications, overdosage, supplying and lots more!

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Clotrimazole

Preferred Pharmaceuticals, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Clotrimazole USP 1% w/w

Purpose

Antifungal Cream

Uses

Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Warnings

  • Do not use on children under 2 years of age unless directed by a doctor.
  • For external use only.
  • Avoid contact with eyes.
  • If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.
  • Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of this 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 the 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. For jock itch, use daily for 2 weeks.
  • If conditions persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.

Other information

  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Close cap tightly after use.

Inactive ingredients

aloe vera, benzyl alcohol, cetearyl alcohol, 2-octyldodecanol, polysorbate 60, sorbitan monostearate, spermwax, vitamin E, water

Questions?

Adverse Drug Event call (800)616-2471
Dist. By MAJOR PHARMACEUTICALS
31778 Enterprise Drive, Livonia, Ml 48150 USA
Re-Order No. 100431

Relabeled by Preferred Pharmaceuticals, Inc.

Principal Display Panel – 1 oz. Carton

Clotrimazole

68788-0070-2

Cures Most

Athlete's Foot

Relieves Itching, Burning, Greaseless, Nonstaining

CLOTRIMAZOLE ANTI-FUNGAL CREAM

CREAM USP, 1%

*Compare To the active ingredient in Lotrimin-AF® NET WT. 28.35 g (1 oz)

Clotrimazole

CLOTRIMAZOLE CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68788-0070(NDC:0904-7822)
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Clotrimazole CLOTRIMAZOLE 10 mg

Inactive Ingredients

Ingredient Name Strength
water
CETOSTEARYL ALCOHOL
POLYSORBATE 60
BENZYL ALCOHOL
SORBITAN MONOSTEARATE
.ALPHA.-TOCOPHEROL ACETATE
Aloe Vera Leaf
OCTYLDODECANOL
cetyl palmitate

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 28.35 in 1 TUBE
2 NDC:68788-0070-2 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 2013-08-06


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