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AU KAH CHUEN ANTIFUNGAL

Medically reviewed on May 8, 2017.

Dosage form: lotion
Ingredients: CLOTRIMAZOLE 1g in 100mL
Labeler: GUANGZHOU NATIONAL PHARMACEUTICAL CO LTD
NDC Code: 66672-001

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

Active Ingredient
Clotrimazole 1.0%

Purpose
Antifungal

Uses
Proven clinically effective in the treatment of most:
athlete’s foot
jock itch
ringworm

Warnings
For external use only

Flammable
Keep away from fire or flame.

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

When using this product avoid contact with the eyes.

Stop use and ask a doctor if
irritation occurs
there is no improvement within:
   2 weeks when used for jock itch
   4 weeks when used for athlete’s foot or ringworm

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

Directions
Wash the affected area and dry thoroughly.
Apply a thin layer of the product over the 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.
   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 condition persists longer, consult a doctor.
This product is not effective on the scalp or nails

Keep container tightly closed, away from heat
Store at 2° to 30° C (36° to 86° F)

Inactive Ingredients
Glycerin, isopropyl alcohol, musk xylol, phenol and purified water.

Questions or Comments? (888) 221-3496 M-F, 9am to 5pm
you may also report serious side effects to the phone number.

AU KAH CHUEN ANTIFUNGAL LOTION
NDC 66672-001-01
0.81 fl oz (24 mL)

AU KAH CHUEN ANTIFUNGAL 
clotrimazole lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66672-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
ISOPROPYL ALCOHOL 
MUSK XYLENE 
PHENOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:66672-001-011 BOTTLE, WITH APPLICATOR in 1 BOX
124 mL in 1 BOTTLE, WITH APPLICATOR
2NDC:66672-001-021 BOTTLE, WITH APPLICATOR in 1 BOX
212 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/08/2017
Labeler - GUANGZHOU NATIONAL PHARMACEUTICAL CO LTD (547447953)
Establishment
NameAddressID/FEIOperations
GUANGZHOU NATIONAL PHARMACEUTICAL CO LTD547447953manufacture(66672-001)

 
GUANGZHOU NATIONAL PHARMACEUTICAL CO LTD

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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