ETADERM ADVANCED ANTIFUNGAL SUPPORT- undecylenic acid cream 
NUEPHASE LLC

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ETADERM Advanced Antifungal Support

Drug Facts

Active ingredient

Undecylenic Acid 25.00%

Purpose

Antifungal

Uses:

Warnings:

For external use only

Do not use

  • on children under 2 years of age unless directed by a doctor

When using this product

  • Avoid contact with eyes.

Stop use and ask a doctor if

  • If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor (within 2 weeks for jock itch).

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

ask a health professional before use.

Directions:

Other Information:

Inactive Ingredients:

Aloe Extract, Eugenia Caryophyllus (Clove) Bud Oil, Helianthus Annuus (Sunflower) Oil, Malaleuca Alternifolia (Tea Tree) Oil, Menthol, Olea Europaea (Olive) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Tocopheryl Acetate (Vitamin E).

Package Labeling:

Label

ETADERM ADVANCED ANTIFUNGAL SUPPORT 
undecylenic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84180-471
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID250 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
CLOVE OIL (UNII: 578389D6D0)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TEA TREE OIL (UNII: VIF565UC2G)  
MENTHOL (UNII: L7T10EIP3A)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
ALMOND OIL (UNII: 66YXD4DKO9)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84180-471-0029 mL in 1 JAR; Type 0: Not a Combination Product03/25/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00503/25/2024
Labeler - NUEPHASE LLC (118900101)

Revised: 3/2024
Document Id: 13874210-91df-0642-e063-6294a90a7c12
Set id: adb12a1c-ece9-4a59-a62c-89d212c57e6f
Version: 1
Effective Time: 20240313
 
NUEPHASE LLC