Label: ATHLETES FOOT- undecylenic acid cream
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Contains inactivated NDC Code(s)
NDC Code(s): 63347-205-01 - Packager: Blaine Labs Inc.
- 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 February 18, 2022
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- DRUG FACTSActive Ingredient
- Purpose
- Keep out of reach of children
- INDICATIONS:
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WARNINGS:
Do not use on children under two years of age unless directed by a physician. For external use only. Avoid contact with eyes. If irritation occurs or if there is no improvement within four (4) weeks (for Athlete's Foot or Ringworm) or within two (2) weeks (for Jock Itch), discontinue use and consult a physician.
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DIRECTIONS:
Wash the affected area with soap and water and dry thoroughly. Apply sparingly over affected area twice daily (morning and night), or as directed by a physician. For Athlete's Foot, pay special attentionto spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For Athlete's Foot and Ringworm, use daily for four (4) weeks. For Jock Itch, use daily for two (2) weeks. If condition persists longer, consult a physician.
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INACTIVE INGREDIENTS:
Water, Hydroxyenthylcellulose, Aloe Barbadensis (Aloe) Leaf Juice, Urea, Disodium EDTA, Coco Caprylate/Caprate, Polysorbate 60, PEG-100 Stearate, Cetyl Alcohol, Glyceryl Stearate, Stearic Acid, Methylparaben, Propylparaben, Sodium Polyacrylate, Hydrogenated Polydecene, Ultramarines, Menthol, Oregano Oil, Peppermint Oil, Triethanolamine
- Athlete's Foot Cream product label
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INGREDIENTS AND APPEARANCE
ATHLETES FOOT
undecylenic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63347-205 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 14.77 mg in 59.148 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5) ALOE VERA LEAF (UNII: ZY81Z83H0X) UREA (UNII: 8W8T17847W) EDETATE DISODIUM (UNII: 7FLD91C86K) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) POLYSORBATE 60 (UNII: CAL22UVI4M) PEG-100 STEARATE (UNII: YD01N1999R) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARIC ACID (UNII: 4ELV7Z65AP) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) ULTRAMARINE BLUE (UNII: I39WR998BI) MENTHOL (UNII: L7T10EIP3A) OREGANO LEAF OIL (UNII: 7D0CGR40U1) PEPPERMINT OIL (UNII: AV092KU4JH) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63347-205-01 59.148 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 04/01/2016 Labeler - Blaine Labs Inc. (017314571) Registrant - Blaine Labs Inc. (017314571)
