MedPath

everfere antifungal cream

85435-004

Approved
Approval ID

3f5a9860-fbae-f8e2-e063-6394a90a3a7b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 21, 2025

Manufacturers
FDA

Guangdong Renhe Guozhuang Biotechnology Co., Ltd.

DUNS: 619052164

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

everfere antifungal cream

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85435-004
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
everfere antifungal cream
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 21, 2025
FDA Product Classification

INGREDIENTS (21)

BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
CAMELLIA JAPONICA SEED OILInactive
Code: U37N0S910T
Classification: IACT
UNDECYLENIC ACIDActive
Quantity: 10 g in 100 g
Code: K3D86KJ24N
Classification: ACTIB
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEInactive
Code: C9H2L21V7U
Classification: IACT
CHAMOMILE FLOWER OILInactive
Code: 60F80Z61A9
Classification: IACT
BUTYROSPERMUM PARKII (SHEA) BUTTERInactive
Code: K49155WL9Y
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
ALPHA-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
SODIUM HYALURONATEInactive
Code: YSE9PPT4TH
Classification: IACT
CERAMIDE NPInactive
Code: 4370DF050B
Classification: IACT
OATMEALInactive
Code: 8PI54V663Y
Classification: IACT
PURSLANEInactive
Code: M6S840WXG5
Classification: IACT
CENTELLA ASIATICA TRITERPENOIDSInactive
Code: 4YS74Q4G4J
Classification: IACT
GLYCERYL 1-STEARATEInactive
Code: 258491E1RZ
Classification: IACT
AQUAInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALOE VERA LEAF OILInactive
Code: JQ7YW886UQ
Classification: IACT
ZINC UNDECYLENATEActive
Quantity: 12 g in 100 g
Code: 388VZ25DUR
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/22/2025

Package Label - Principal Display Panel

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INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/22/2025

Use

■Proven antifungal treatment
■Relieves itching, burning, cracking, and scaling associated with: Athlete's Foot, Jock Itch, Ringworm.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/22/2025

Active Ingredient(s)

Undecylenic Acid 10% (w/w)
Zinc Undecylenate 12% (w/w)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/22/2025

Purpose

Anti-fungal

WARNINGS SECTION

LOINC: 34071-1Updated: 9/22/2025

Warnings

For external use only.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/22/2025

Do not use

Do not use on children under 2 years of age unless directed by a
doctor.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/22/2025

When using this product, avoid contact with the eyes.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/22/2025

Stop use and ask a doctor if: mlrritation occurS,
There is no improvement within 4 weeks (for athlete's foot and
ringworm) or within 2 weeks (for jock itch).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/22/2025

Keep out of reach of children. mif swallowed, get medical help or
contact a Poison control center(1-800-22-1222) right away,

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/22/2025

Directions

1. Do a patch test, then clean and thoroughly dry the affected area,
2, Apply a thin layer of the product to the affected area twice daily (morning and evening).
3. If symptoms persist or worsen, consult a health care professional.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/22/2025

Other information

■Do not use if seal on product opening is broken or missing,
■Store at room temperature 15*-30C(59-86°F).
■Read all label directions, Keep carton, it contains important information.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/22/2025

Inactive ingredients

Aqua (Water), Glycerin, Aloe Barbadensis (Aloe Vera) Leaf Water, Butylene Glycol, Propylene Glycol, Cetearyl Alcohol, Glyceryl
Monostearate, Chamomilla Recutita (Matricaria) Flower Water, Caprylic/Capric Tigyceride, Butyrospermum Parki (Shea) Butter
Dimethicone, Cllidal 0atmeal, Centella Asiatica Extract, GlyceryI Stearate, Camellia Japonica Seed 0il, Ceramide NP, Potassium
Sorbate, Tocopherol (Vitamin E), Portulaca 0leracea Extract, Sodium Hyaluronate.

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 9/22/2025

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