Label: XTRACARE ANTIFUNGAL FOOT- tolnaftate spray
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Contains inactivated NDC Code(s)
NDC Code(s): 57337-056-01 - Packager: Rejoice International
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated September 13, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only.
Flammable. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120oF (49oC).
When using this product
- avoid eyes & face
- use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.
Stop use and ask a doctor if
- irritation occurs
- there is no improvement after 4 weeks
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DOSAGE & ADMINISTRATION
Directions
- wash 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
- for athlete's foot: pay special attention to spaces betwen the toes; wear well-fitted, ventilated shoes and change shoes and socks at least once a day.
- use daily for 4 weeks; if condition persists longer, consult a doctor
- to prevent athlete's foot, apply once or twice daily (morning and night)
- in case of clogging, clean nozzle with a pin
- INACTIVE INGREDIENT
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OTHER SAFETY INFORMATION
Other information store between 68o to 77oF (20o to 25oC)
Questions/Comments? 1-855-345-5575
*This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc., owner of the registered trademark Tinactin®
DISTRIBUTED BY
REJOICE INTERNATIONAL, INC
NORTHVILLE, MI 48168 USA
MADE IN CHINA
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
XTRACARE ANTIFUNGAL FOOT
tolnaftate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57337-056 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1 g in 100 g Inactive Ingredients Ingredient Name Strength BUTANE (UNII: 6LV4FOR43R) PROPANE (UNII: T75W9911L6) ALCOHOL (UNII: 3K9958V90M) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57337-056-01 100 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/11/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 02/11/2014 Labeler - Rejoice International (078741245) Establishment Name Address ID/FEI Business Operations Zhejiang Ludao Cosmetics Co., Ltd. 679885595 manufacture(57337-056)
