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Budpak Antifungal Clotrimazole

Medically reviewed on November 20, 2017

Dosage form: cream
Ingredients: CLOTRIMAZOLE 0.01g in 1g
Labeler: Budpak Inc.
NDC Code: 27293-025

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 eyes.

Stop using this product and ask a doctor

  • 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 this and all drugs 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 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 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 20ºC to 25º C (68ºF to 77ºF)
  • Lot No. & Exp. Date: see crimp of tube.

Inactive ingredients

Purified Water, Mineral Oil, Cetearyl Alcohol, Petrolatum, Glyceryl Stearate, Propylene Glycol, Polysorbate 60, Sorbitan mono stearate, Methylparaben, Propylparaben.

PRINCIPAL DISPLAY PANEL

Budpak Antifungal Cream

Clotrimazole 1%

NET WT 0.5 OZ (14 g)

BUDPAK ANTIFUNGAL CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-025
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
MINERAL OIL 
CETOSTEARYL ALCOHOL 
PETROLATUM 
GLYCERYL MONOSTEARATE 
PROPYLENE GLYCOL 
POLYSORBATE 60 
SORBITAN MONOSTEARATE 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:27293-025-011 TUBE in 1 BOX
1NDC:27293-025-1414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/17/2012
Labeler - Budpak Inc. (183224849)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-025)

 
Budpak Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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