OTC Medication Information: CAREALL Clotrimazole

CAREALL CLOTRIMAZOLE- clotrimazole cream
New World Imports, 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.

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Keep out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

  • Cures most athlete’s foot, jock itch and ringworm.
  • Relieves itching, burning, cracking, scaling, and discomfort which accomany these conditions.

Warnings

For external use only.

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

When using this product avoide contact with eyes

Stop use and ask doctor if

  • irritation occurs
  • there is no improvement in 4 weeks (for athlete’s foot for ringworm) or 2 weeks (for jock itch)

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete’s foot, pay special attention to spaces between the toes, wear well fitting, ventilated shoes and change shoes and socks at least once daily
  • for atlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Inactive Ingredients

Cetomacrogol 1000, Cetostearyl Alcohol, Liquid Paraffin, Methylparaben, Propylene Glycol, Propylparaben, Water, White Soft Paraffin

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CAREALL CLOTRIMAZOLE
clotrimazole cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-063
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
clotrimazole (CLOTRIMAZOLE) clotrimazole 1 g in 1 g
Inactive Ingredients
Ingredient Name Strength
CETETH-20
CETOSTEARYL ALCOHOL
MINERAL OIL
METHYLPARABEN
PROPYLPARABEN
water
PARAFFIN
PROPYLENE GLYCOL
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51824-063-01 28 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 03/21/2016
Labeler — New World Imports, Inc (075372276)

Revised: 10/2019 New World Imports, 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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