SPL v1
SPL
SPL Set ID 3c41ed29-d5e6-fefb-e063-6294a90a2d11
Route
TOPICAL
Published
Effective Date 2025-08-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Peppermint (1 g)
Inactive Ingredients
Tea Tree Oil Almond Oil Bergamot Oil Grapefruit Oil Jojoba Oil Lavender Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-13

Description

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


Medication Information

Warnings and Precautions

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

Indications and Usage

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

Dosage and Administration

Use 1-2 Times A Day

Description

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

Section 50565-1

Keep of out reach of children

Section 50566-9

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

Section 51727-6

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

Section 51945-4

Section 55105-1

Penetates The NailRepair.

Section 55106-9

Active ingredient.

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


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Use 1-2 Times A Day

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

Keep of out reach of children

Section 50566-9 (50566-9)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Penetates The NailRepair.

Section 55106-9 (55106-9)

Active ingredient.

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)