ETADERM ADVANCED ANTIFUNGAL SUPPORT- undecylenic acid cream

ETADERM Advanced Antifungal Support by

Drug Labeling and Warnings

ETADERM Advanced Antifungal Support by is a Otc medication manufactured, distributed, or labeled by NUEPHASE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Undecylenic Acid 25.00%

Purpose

Antifungal

Uses:

• For the cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm).
• For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort associated to fungal infections.

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:

• Clean the affected area and dry thoroughly.
• Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
• Supervise children in the use of this product.
• For arthlete's foot: Pay special attention to 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 4 weeks.
• If condition persists longer, consult a doctor.
• This product is no effective on the scalp or nails.

Other Information:

• Protect the product in this container from excessive heat and direct sun.

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:

INGREDIENTS AND APPEARANCE

ETADERM ADVANCED ANTIFUNGAL SUPPORT 
undecylenic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84180-471
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84180-471-00	29 mL in 1 JAR; Type 0: Not a Combination Product	03/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	03/25/2024

Labeler - NUEPHASE LLC (118900101)