HUA TUO XIAN GAO- clotrimazole ointment 
SHANGHAI SONGHUA PHARMACEUTICAL CO LTD

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.

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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)IMAGE OF CARTON

HUA TUO XIAN GAO 
clotrimazole ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76182-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
PETROLATUM (UNII: 4T6H12BN9U)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76182-001-0120 g in 1 TUBE; Type 0: Not a Combination Product04/28/2011
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/FEIBusiness Operations
SHANGHAI SONGHUA PHARMACEUTICAL CO LTD420355463manufacture(76182-001)

Revised: 10/2018
Document Id: 0b23b963-0369-4547-bcba-fa11755b4e00
Set id: cea1065e-4123-4a3b-aebe-4d934b9cc055
Version: 2
Effective Time: 20181015
 
SHANGHAI SONGHUA PHARMACEUTICAL CO LTD