Label: ELON DUAL DEFENSE ANTI FUNGAL FORMULA- undecylenic acid liquid
- NDC Code(s): 71171-778-15
- Packager: Little Giant Holdings 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.
Updated January 10, 2017
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- Drug Facts
- Active ingredients:
For external use only.
- Wash affected area well, and let product sit for 1-2 minutes before rinsing.
- Make sure to dry affected area thoroughly.
- Supervise children in the use of this product
- For athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at leat once daily
- Use 1-2 times daily.
- Use daily for 4 weeks; if condition persists longer, ask a doctor
- This product is not effective on the scalp or nails
- Inactive ingredients:
- Other information
- Package Labeling:
INGREDIENTS AND APPEARANCE
ELON DUAL DEFENSE ANTI FUNGAL FORMULA
undecylenic acid liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71171-778 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 250 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CITRUS MAXIMA SEED (UNII: 083X55C543) ALCOHOL (UNII: 3K9958V90M) TEA TREE OIL (UNII: VIF565UC2G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71171-778-15 1 in 1 BOX 01/02/2017 1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 01/02/2017 Labeler - Little Giant Holdings LLC (080461006)