Label: DERMACED MAXIMUM STRENGTH ANTI-FUNGAL- undecylenic acid liquid
- NDC Code(s): 71515-832-01
- Packager: Dermaced, 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 June 29, 2017
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- DRUG FACTS:
- Active Ingredient:
For external use only.
• Clean and dry affected area with soap and water and dry thoroughly. • Apply a thin layer to the affected area twice daily (morning and night) or as directed by physician. • For athletes foot, pay special attention to the space between the toes, and wear well-fitting ventilated shoes and socks. • For athletes foot and ringworm. If condition persists for longer, consult a physician, • Intended for use by normally healthy adults only. Persons under the age of 18, or those with highly sensitive or allergic skin should use only as directed by physician. • This product is not meant to be applied directly to the scalp or nails.
- Other Ingredients:
- Package Labeling:
INGREDIENTS AND APPEARANCE
DERMACED MAXIMUM STRENGTH ANTI-FUNGAL
undecylenic acid liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71515-832 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 CITRONELLA OIL (UNII: QYO8Q067D0) LAVENDER OIL (UNII: ZBP1YXW0H8) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) ALMOND OIL (UNII: 66YXD4DKO9) JOJOBA OIL (UNII: 724GKU717M) CLOVE OIL (UNII: 578389D6D0) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71515-832-01 1 in 1 BOX 06/29/2017 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 06/29/2017 Labeler - Dermaced, LLC (080703517)