OTC Medication Information: Lakesia

LAKESIA- clotrimazole cream
OPMX LLC

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

Uses

  • cures most athlete’s foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

Do not use on children under 2 years of age except under the advice and supervision of a doctor

For external use only

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks(for athlete’s foot and ringworm) or 2 weeks (for jock itch)
  • do not use for diaper rash

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer cover 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 the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day
  • for athlete’s foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
  • if conditions persist longer, ask a doctor
  • this product is not effective on the scalp or nails

Other information

  • store between 2°and 30° C (36° and 86° F)

Inactive ingredients

Benzyl alcohol, Carbomer940, Cetyl alcohol, Glycerin, Clyceryl monostearate, Light liquid paraffin, Myristoyl/palmitoyl oxostearamide/arachamide MEA, PEG-15 glyceryl stearate, Stearic acid, Trolamine, Purified water

Lakesia

Lakesia
(click image for full-size original)
LAKESIA
clotrimazole cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-064
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE 1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
CARBOMER 940
CETYL ALCOHOL
GLYCERIN
GLYCERYL MONOSTEARATE
PARAFFIN
STEARIC ACID
TROLAMINE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69729-064-20 1 TUBE in 1 BOX contains a TUBE
1 20 g in 1 TUBE This package is contained within the BOX (69729-064-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 07/02/2015
Labeler — OPMX LLC (029918743)

Revised: 07/2015 OPMX LLC

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.

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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