Otc - Active Ingredient
Active ingredient
Clotrimazole 1.0%
Hua Tuo Xian Gao
FDA Label NDC 76182-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shanghai Songhua Pharmaceutical Co Ltd for the product Hua Tuo Xian Gao (NDC 76182-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antifungal
Indications & Usage
Uses
For the cure of:
athlete’s foot
jock itch
ringworm
Relieves:
itching
scaling
cracking
burning
discomfort
soreness
irritation
redness
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
on children under 12 years of age unless directed by a doctor
if pregnant
if nursing
Otc - When Using
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
Otc - 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
Otc - 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
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
Storage And Handling
Other information
keep container tightly closed
store between 2° and 30° C (36° to 86° F)
Inactive Ingredient
Inactive ingredients
Benzoic acid, camphor, Chimonanthus praecox (L.) Link. flower oil, insect wax (cera chinensis), petrolatum, and salicylic acid.
Otc - Questions
Questions or comments?
(888) 221-3496 M-F 9am-5pm
you may also report serious side effects to this phone number
Package Label.Principal Display Panel
HUA TUO XIAN GAO Antifungal Ointment NDC 76182-001-01 20 g (0.7 oz)
Image Of Carton (Box)
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