OTC Medication Information: Major Clotrimazole

MAJOR CLOTRIMAZOLE- clotrimazole cream
REMEDYREPACK INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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-Oder No. 100431

PRINCIPAL DISPLAY PANEL

DRUG: Major Clotrimazole

GENERIC: CLOTRIMAZOLE

DOSAGE: CREAM

ADMINSTRATION: TOPICAL

NDC: 70518-0207-0

PACKAGING: 14.17 g in 1 TUBE

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

  • CLOTRIMAZOLE 10mg in 1g

INACTIVE INGREDIENT(S):

  • .ALPHA.-TOCOPHEROL ACETATE
  • ALOE VERA LEAF
  • CETYL PALMITATE
  • OCTYLDODECANOL
  • SORBITAN MONOSTEARATE
  • BENZYL ALCOHOL
  • CETOSTEARYL ALCOHOL
  • POLYSORBATE 60
  • WATER
Remedy_Label
(click image for full-size original)
MAJOR CLOTRIMAZOLE
clotrimazole cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-0207(NDC:0904-7822)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE 10 mg in 1 g
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 Multilevel Packaging
1 NDC:70518-0207-0 1 TUBE in 1 CARTON contains a TUBE
1 14.17 g in 1 TUBE This package is contained within the CARTON (70518-0207-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 02/28/2017
Labeler — REMEDYREPACK INC. (829572556)

Revised: 02/2020 REMEDYREPACK INC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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