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Budpak Antifungal Miconazole Nitrate

Medically reviewed on November 29, 2017

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 0.02g in 1g
Labeler: Budpak Inc.
NDC Code: 27293-023

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.

Budpak Antifungal Miconazole Nitrate Cream

Active Ingredient

Miconazole Nitrate 2.0%

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 15ºC to 30º C (59ºF to 86º F)
  • Lot No. & Exp. Date: see crimp of tube.

Inactive Ingredients

Benzoic Acid, Butylated Hydroxy Anisole, Mineral Oil, PEGlicol-5-Oleate, Pegoxol-7 Stearate, Purified Water.

PRINCIPAL DISPLAY PANEL

Budpak Antifungal Cream

Miconazole Nitrate 2%

Antifungal for Athlete’s Foot and Jock Itch

NET WT 0.5 OZ (14 g)

BUDPAK ANTIFUNGAL MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-023
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
BUTYLATED HYDROXYANISOLE 
MINERAL OIL 
PEG-5 OLEATE 
PEGOXOL 7 STEARATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:27293-023-011 TUBE in 1 BOX
1NDC:27293-023-1414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C11/29/2013
Labeler - Budpak Inc. (183224849)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-023)

 
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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