HUA TUO XIAN GAO- clotrimazole ointment

HUA TUO XIAN GAO by

Drug Labeling and Warnings

HUA TUO XIAN GAO by is a Otc medication manufactured, distributed, or labeled by SHANGHAI SONGHUA 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

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

DO NOT USE

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

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

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
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 2º and 30º C (36º to 86º F)

INACTIVE INGREDIENT

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

HUA TUO XIAN GAO 
clotrimazole ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76182-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
PETROLATUM (UNII: 4T6H12BN9U)
SALICYLIC ACID (UNII: O414PZ4LPZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76182-001-01	20 g in 1 TUBE; Type 0: Not a Combination Product	04/28/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/28/2011

Labeler - SHANGHAI SONGHUA PHARMACEUTICAL CO LTD (420355463)

Establishment
Name	Address	ID/FEI	Business Operations
SHANGHAI SONGHUA PHARMACEUTICAL CO LTD		420355463	manufacture(76182-001)