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HUA TUO XIAN GAO

Dosage form: ointment
Ingredients: CLOTRIMAZOLE 1mg in 100g
Labeler: SHANGHAI SONGHUA PHARMACEUTICAL CO LTD
NDC Code: 76182-001

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

For the cure of:
athlete’s foot
jock itch
ringworm

Relieves:
itching
scaling
cracking
burning
discomfort
soreness
irritation
redness

Warnings
For external use only

Do not use
on children under 12 years of age unless directed by a doctor
if pregnant
if nursing

When using this product
avoid contact with the eyes
do not use the following on the skin:
soap
alcohol
hydrogen peroxide
iodine or sulphur compounds

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
Adults and children 12 years of age or older:
Wash the affected area and dry thoroughly. In areas where the skin is thickened, soak in warm water to soften it first
Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor.
For athlete’s foot:
Pay special attention to spaces between the toes. It is useful to apply at night on cotton balls wedged 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.
Children under 12 years: Do not use unless directed by a doctor

Other information
keep container tightly closed
store between 2º and 30º C (36º to 86º F)

Inactive ingredients
Benzoic acid, camphor, Chimonanthus praecox (L.) Link. flower oil, insect wax (cera chinensis), petrolatum, and salicylic acid.

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

HUA TUO XIAN GAO Antifungal Ointment NDC 76182-001-01  20 g (0.7 oz)

HUA TUO XIAN GAO 
clotrimazole ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76182-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE1 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
CAMPHOR (SYNTHETIC) 
PETROLATUM 
SALICYLIC ACID 
Packaging
#Item CodePackage Description
1NDC:76182-001-0120 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/28/2011
Labeler - SHANGHAI SONGHUA PHARMACEUTICAL CO LTD (420355463)
Establishment
NameAddressID/FEIOperations
SHANGHAI SONGHUA PHARMACEUTICAL CO LTD420355463manufacture

Revised: 04/2011
 
SHANGHAI SONGHUA 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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