HUA TUO XIAN GAO ANTIFUNGAL- clotrimazole ointment 
MADISON ONE ACME INC

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
■ if pregnant
■ if nursing
■ on children under 12 years of age unless directed by a doctor

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

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

Clotrimazole 1.0%

Cure Athlete’s Foot Jock Itch & Ringworm

NDC 55614-650-01

20 g (0.7 oz)

Odorless

Non-Greasy

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HUA TUO XIAN GAO ANTIFUNGAL 
clotrimazole ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55614-650
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55614-650-011 in 1 BOX04/01/2020
120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/01/2020
Labeler - MADISON ONE ACME INC (096196758)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(55614-650)

Revised: 4/2020
Document Id: 45073a79-ddfc-4cb6-857b-c20831eb87b1
Set id: e11c4d87-8dc2-44b1-bf6b-12e7ef4f3d1d
Version: 1
Effective Time: 20200413
 
MADISON ONE ACME INC