Label: RELISPRAY ANTIFUNGAL LIQUID- tolnaftate aerosol, spray
- NDC Code(s): 46063-810-12
- Packager: Midas-Care Pharmaceuticals Pvt. Ltd.
- 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.
Updated January 28, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only
Flammable. Do not use while smoking or near heat or flame.
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 and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)
- wash the affected area and dry thoroughly
- shake can well and apply a thin layer over the affected area twice daily (morning and night)
- supervise children in the use of this product
- for athlete's foot:
- pay special attention to spaces 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
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 128 g Can Label
INGREDIENTS AND APPEARANCE
RELISPRAY ANTIFUNGAL LIQUID
tolnaftate aerosol, spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46063-810 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV) Tolnaftate 0.01 g in 1 g Inactive Ingredients Ingredient Name Strength Butylated hydroxytoluene (UNII: 1P9D0Z171K) FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) Polyethylene glycol 400 (UNII: B697894SGQ) LIQUEFIED PETROLEUM GAS (UNII: 5K616HU99V) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46063-810-12 128 g in 1 CAN; Type 0: Not a Combination Product 03/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333C 03/01/2022 Labeler - Midas-Care Pharmaceuticals Pvt. Ltd. (862273427)