Label: CRYSTAL FLUSH MAXIMUM STRENGTH ANTI-FUNGAL FORMULA- tolnaftate solution
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Contains inactivated NDC Code(s)
NDC Code(s): 80569-101-15 - Packager: Triple Point Group, LLC
- 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 April 28, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose:
- Uses:
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Warnings:
For external use only.
- Avoid contact with the eyes.
- Do not use on children under 2 years of age unless directed by a doctor.
- If treating athlete's foot and ringworms: Stop use and consult a doctor if irritation occurs or if there is no improvement within 4 weeks.
- If swallowed, get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
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Directions:
Clean or wash the affected area and dry throughly. Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by doctor. For athletes foot, pay special attention to space between toes. Wear well-fitting, ventilated shoes, and 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. Supervise children in the use of this product.
- Inactive ingredients:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CRYSTAL FLUSH MAXIMUM STRENGTH ANTI-FUNGAL FORMULA
tolnaftate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80569-101 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 mL Inactive Ingredients Ingredient Name Strength ALMOND OIL (UNII: 66YXD4DKO9) CITRONELLA OIL (UNII: QYO8Q067D0) LAVENDER OIL (UNII: ZBP1YXW0H8) TEA TREE OIL (UNII: VIF565UC2G) JOJOBA OIL (UNII: 724GKU717M) CLOVE OIL (UNII: 578389D6D0) AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80569-101-15 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/07/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 04/07/2021 Labeler - Triple Point Group, LLC (058482713) Registrant - Triple Point Group, LLC (058482713)
