MedPath

HOUKEA Rapid Mole Spot Elimination Gel

Approved
Approval ID

3b35c488-144b-bf46-e063-6394a90a0843

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 31, 2025

Manufacturers
FDA

Guangzhou Houkea Biotechnology Co., Ltd.

DUNS: 456717258

Products 1

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

GLYCERIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84984-006
Product Classification
G
Generic Name
GLYCERIN
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 31, 2025
FDA Product Classification

INGREDIENTS (9)

LAMINARIA JAPONICAActive
Quantity: 0.01 mg in 50 mg
Code: WE98HW412B
Classification: ACTIB
CHAMOMILEActive
Quantity: 0.01 mg in 50 mg
Code: FGL3685T2X
Classification: ACTIB
AVOCADO OILActive
Quantity: 0.01 mg in 50 mg
Code: 6VNO72PFC1
Classification: ACTIB
GLYCERINInactive
Quantity: 4 mg in 50 mg
Code: PDC6A3C0OX
Classification: IACT
CHONDRUS CRISPUS CARRAGEENANActive
Quantity: 0.01 mg in 50 mg
Code: UE856F2T78
Classification: ACTIB
WATERInactive
Quantity: 45.75 mg in 50 mg
Code: 059QF0KO0R
Classification: IACT
CARBOMER HOMOPOLYMER TYPE AInactive
Quantity: 0.1 mg in 50 mg
Code: F68VH75CJC
Classification: IACT
TROLAMINEInactive
Quantity: 0.1 mg in 50 mg
Code: 9O3K93S3TK
Classification: IACT
ALLANTOINInactive
Quantity: 0.01 mg in 50 mg
Code: 344S277G0Z
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/31/2025

1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/31/2025

Rapid Mole Spot Elimination Gel;Mole Remover Gel;Spot Gel

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/31/2025

AVOCADO OIL、LAMINARIA JAPONICA、CHONDRUS CRISPUS CARRAGEENAN、CHAMOMILE

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 7/31/2025

Clean and dry your skin, apply an appropriate amount of this product evenly on the affected area with skin problems such as spots, and gently massage until absorbed.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/31/2025

Dissolves skin acne; removes moles; lightens dark spots; reduces skin blemishes; makes skin smoother; restores skin health

WARNINGS SECTION

LOINC: 34071-1Updated: 7/31/2025

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 7/31/2025

Discontinue use if signs of irritation or rash occur.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 7/31/2025

Discontinue use if signs of irritation or rash occur.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/31/2025

Please keep out of reach of children. Do not swallow.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 7/31/2025

Store in a cool and dry place.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/31/2025

WATER、GLYCERIN、CARBOMER HOMOPOLYMER TYPE A、TROLAMINE、ALLANTOIN

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/31/2025

Clean and dry your skin, apply an appropriate amount of this product evenly on the affected area with skin problems such as spots, and gently massage until absorbed.

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HOUKEA Rapid Mole Spot Elimination Gel - FDA Drug Approval Details