HUA TUO XIAN GAO ANTIFUNGAL- clotrimazole ointment

HUA TUO XIAN GAO ANTIFUNGAL by

Drug Labeling and Warnings

HUA TUO XIAN GAO ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by MADISON ONE ACME INC, Zhejiang Dingtai 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
■ if pregnant
■ if nursing
■ on children under 12 years of age unless directed by a doctor

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 flower oil, petrolatum, salicylic acid, and yellow wax.

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

Clotrimazole 1.0%

Cure Athlete’s Foot Jock Itch & Ringworm

NDC: 55614-650-01

20 g (0.7 oz)

Odorless

Non-Greasy

INGREDIENTS AND APPEARANCE

HUA TUO XIAN GAO ANTIFUNGAL 
clotrimazole ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55614-650
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 g

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CHIMONANTHUS PRAECOX FLOWER OIL (UNII: EB4HIB5MLF)
PETROLATUM (UNII: 4T6H12BN9U)
SALICYLIC ACID (UNII: O414PZ4LPZ)
YELLOW WAX (UNII: 2ZA36H0S2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55614-650-01	1 in 1 BOX	04/01/2020
1		20 g in 1 TUBE; 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	04/01/2020

Labeler - MADISON ONE ACME INC (096196758)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd		420598724	manufacture(55614-650)