AU KAH CHUEN ANTIFUNGAL- clotrimazole lotion

AU KAH CHUEN ANTIFUNGAL by

Drug Labeling and Warnings

AU KAH CHUEN ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by GUANGZHOU NATIONAL PHARMACEUTICAL CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient
Clotrimazole 1.0%

PURPOSE

Purpose
Antifungal

INDICATIONS & USAGE

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

WARNINGS

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

When using this product avoid contact with the eyes.

STOP USE

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

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

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

AU KAH CHUEN ANTIFUNGAL 
clotrimazole lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66672-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MUSK XYLENE (UNII: 1ZAO16GU5K)
PHENOL (UNII: 339NCG44TV)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66672-001-01	1 in 1 BOX	05/08/2017
1		24 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
2	NDC: 66672-001-02	1 in 1 BOX	05/08/2017
2		12 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	05/08/2017

Labeler - GUANGZHOU NATIONAL PHARMACEUTICAL CO LTD (547447953)

Establishment
Name	Address	ID/FEI	Business Operations
GUANGZHOU NATIONAL PHARMACEUTICAL CO LTD		547447953	manufacture(66672-001)