MedPath

Gray Nail Essence Oil

Approved
Approval ID

3c41ed29-d5e6-fefb-e063-6294a90a2d11

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 13, 2025

Manufacturers
FDA

Guangzhou ChuanMa International Trading Co.,Ltd.

DUNS: 510247477

Products 1

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

Peppermint Oil 1%

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85593-007
Application NumberM029
Product Classification
M
Marketing Category
C200263
G
Generic Name
Peppermint Oil 1%
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 13, 2025
FDA Product Classification

INGREDIENTS (7)

TEA TREE OILInactive
Code: VIF565UC2G
Classification: IACT
ALMOND OILInactive
Code: 66YXD4DKO9
Classification: IACT
BERGAMOT OILInactive
Code: 39W1PKE3JI
Classification: IACT
GRAPEFRUIT OILInactive
Code: YR377U58W9
Classification: IACT
JOJOBA OILInactive
Code: 724GKU717M
Classification: IACT
LAVENDER OILInactive
Code: ZBP1YXW0H8
Classification: IACT
PEPPERMINT OILActive
Quantity: 1 g in 100 mL
Code: AV092KU4JH
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/14/2025

labeling

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/14/2025

Penetates The NailRepairOnychomycosis deeply-StrongformulaRenew damaged nailaster-Multi-PurposeFor varioustypes of damagednails

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/14/2025

Active ingredient.
Pepper-mint Oil 1%... PurposePenetates The NailRepair

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/14/2025

Do not use on molesbirthmarks, warts with hair growingfrom them, genital warts, or wartson the face or mucous membranes

WARNINGS SECTION

LOINC: 34071-1Updated: 8/14/2025

The labeling of the productcontains the following warningsunder the heading "warnings(1)For products containing anyingredient identified in S M028.10(i) For external use only.(ii) Do not use this product onirritated skin, on any area that isinfected or reddened. if you are adiabetic, or if you have poor bloodcirculation

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/14/2025

Use 1-2 Times A Day

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/14/2025

Penetates The NailRepair.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/14/2025

Tea TreeOilAlmond OilPepper-mint Oiljojoba OilBerg-amot OilLavender OilGrapeseed 0il

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/14/2025

Keep of out reach of children

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Gray Nail Essence Oil - FDA Drug Approval Details