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| Product NDC Code | 55614-650 | ||||
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| Drug Name | Hua tuo xian gao antifungal |
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| Type | Brand | ||||
| Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 418475 | ||||
| Application Number | part333C | ||||
| Labeler Name | MADISON ONE ACME INC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Clotrimazole 1.0%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Benzoic acid, camphor, chimonanthus praecox flower oil, petrolatum, salicylic acid, and yellow wax.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses ■ For the cure of: ■ athlete’s foot ■ jock itch ■ ringworm ■ Relieves: ■ itching ■ scaling ■ cracking ■ burning ■ discomfort ■ soreness ■ irritation ■ redness
Purpose
Information about the drug product’s indications for use.Purpose Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.HUA TUO XIAN GAO ANTIFUNGAL Clotrimazole CLOTRIMAZOLE CLOTRIMAZOLE BENZOIC ACID CAMPHOR (SYNTHETIC) CHIMONANTHUS PRAECOX FLOWER OIL PETROLATUM SALICYLIC ACID YELLOW WAX
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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 box-01.jpg
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use ■ if pregnant ■ if nursing ■ on children under 12 years of age unless directed by a doctor
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? (888) 221-3496 M-F 9am-5pm ■ you may also report serious side effects to this phone number
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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
Storage and handling
Information about safe storage and handling of the drug product.Other information ■ keep container tightly closed ■ store between 2º and 30º C (36º to 86º F)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API