Label: ANTIFUNGAL- tolnaftate spray
- NDC Code(s): 11822-0539-1
- Packager: Rite Aid Corporation
- Category: HUMAN OTC DRUG LABEL
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 June 11, 2019
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- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Flammable: Do not use while smoking or near heat or flame
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Directions
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- wash affected area and dry thoroughly
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- shake can well and spray a thin layer over affected area twice daily (morning and night)
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- supervise children in the use of this product
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- use daily for 2 weeks; if condition persists longer, ask a doctor
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- this product is not effective on the scalp or nails
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- in case of clogging, clean nozzle with a pin
- Other information
- Inactive ingredients
- Questions or comments?
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
ANTIFUNGAL
tolnaftate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0539 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 ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) ISOBUTANE (UNII: BXR49TP611) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PROPYLENE CARBONATE (UNII: 8D08K3S51E) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) TALC (UNII: 7SEV7J4R1U) ALCOHOL (UNII: 3K9958V90M) Product Characteristics Color WHITE (off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0539-1 130 g in 1 CAN; Type 0: Not a Combination Product 05/12/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 05/12/2016 Labeler - Rite Aid Corporation (014578892)