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- NDC Code(s): 84010-075-01
- Packager: Jiangxi Hemei Pharmaceutical Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 20, 2025
If you are a consumer or patient please visit this version.
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- Active Ingredient
Tolnaftate 1%
- Purpose
Antifungal
- Use
.Effectivein treating athlete's foot (tineapedis)
.Helps prevent athlete's foot with regular use
.For effective relief ofitching, cracking, burning, scaling and discomfort
- Warnings
For external use only
Extremely Flammable do not use while smoking or near heat or flame. - Do not use
on children under 2 years of age unless directed by a doctor.
- When Using
this product avoid contact with the eyes
.Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
.Do not puncture or incinerate. Contents under pressure, Do not store at temperatures above 120°F - Stop Use
·Irritation occurs
·There is no improvement within 4 weeks. - Ask Doctor
·Irritation occurs
·There is no improvement within 4 weeks. - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a poison control center right away.
- Directions
·Wash the affected area and dry thoroughly
·Shake can well and spray a thin layer over affected area twice daily (morning and night)
·Supervise children in the use of this product
·pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once
daily
·Use daily for 4 weeks; if condition persists longer, ask a doctor
·To prevent athlete's foot, apply once or twice daily (morning and/or night, or as directed by a doctor)
·This product is not effective on the scalp or nails. - Other information
Store between 20-25°C (68-77°F)
- Inactive ingredients
alcohol,benzoic acid,euphorbia hirta whole,phellodendron amurense bark,phenylephrine hydrochloride,pseudolarix
amabilis bark,salicylic acid,sophora flavescens root,Probiotic. - PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
ALVEORA FOOT ODOR PROBIOTIC
tolnaftate 1% foot odor probiotic sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84010-075 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1g in100mL Inactive Ingredients Ingredient Name Strength PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G) SALICYLIC ACID (UNII: O414PZ4LPZ) ALCOHOL (UNII: 3K9958V90M) PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) BENZOIC ACID (UNII: 8SKN0B0MIM) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) EUPHORBIA HIRTA WHOLE (UNII: L13YF113GN) PSEUDOLARIX AMABILIS BARK (UNII: 49G13A93VE) LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84010-075-01 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/21/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 02/21/2025 Labeler -Jiangxi Hemei Pharmaceutical Co., Ltd(724892056)
Establishment Name Address ID/FEI Business Operations Jiangxi Hemei Pharmaceutical Co., Ltd 724892056 manufacture(84010-075)
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ALVEORA FOOT ODOR PROBIOTIC- tolnaftate 1% foot odor probiotic spray
Number of versions: 1
Published Date (What is this?) | Version | Files |
---|---|---|
Feb 24, 2025 | 1 (current) | download |
RxNorm
ALVEORA FOOT ODOR PROBIOTIC- tolnaftate 1% foot odor probiotic spray
Under Review - Editing is pending for RxNorm. If in scope, these drugs will include RxNorm normal forms when editing is complete.
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NDC Codes
ALVEORA FOOT ODOR PROBIOTIC- tolnaftate 1% foot odor probiotic spray
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
NDC | |
---|---|
1 | 84010-075-01 |