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SPL v1

SPL

SPL Set ID 3d94a141-4f28-dd09-e063-6394a90ae091

Route

CUTANEOUS

Published

Effective Date 2025-08-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Nicotine (30 g)

Inactive Ingredients

Peppermint Clove Oil Star Anise Oil Ginger Oil Sweet Marjoram Oil

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2025-08-01

Description

Nicotine

Medication Information

Warnings and Precautions

if you are pregnant or breastfeeding,use this product only under the supervision of a healthcare professional,Smoking poses serious risks to your baby.

Indications and Usage

Apply one patch every 24 hours to clean,dry,hairless skin.Remove backing and apply immediately.Press firmly for 10 seconds.

Wash hands after applying or removing.Fold used patch with sticky sides together and place in pouch for disposal.Change application site daily to avoid skin irritation.

Dosage and Administration

Use one 21 mg Patch/day

Use one 14 mg Patch/day

Use one 7 mg Patch/day

Description

Nicotine

Section 50565-1

KEEP OUT OF REACH OF CHILDREN AND PETS

Section 51727-6

Clove Essential Oil,Star Anise Essential Oil,Sweet Orange Essential Oil,Peppermint Essential Oil,Ginger Essential Oil and Sweet Marjoram Essential Oil.

Section 51945-4

Section 55105-1

It is used for smokers to quit smoking

Section 55106-9

Nicotine

Structured Label Content

Indications and Usage (34067-9)

Apply one patch every 24 hours to clean,dry,hairless skin.Remove backing and apply immediately.Press firmly for 10 seconds.

Wash hands after applying or removing.Fold used patch with sticky sides together and place in pouch for disposal.Change application site daily to avoid skin irritation.

Dosage and Administration (34068-7)

Use one 21 mg Patch/day

Use one 14 mg Patch/day

Use one 7 mg Patch/day

Warnings and Precautions (34071-1)

if you are pregnant or breastfeeding,use this product only under the supervision of a healthcare professional,Smoking poses serious risks to your baby.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN AND PETS

Section 51727-6 (51727-6)

Clove Essential Oil,Star Anise Essential Oil,Sweet Orange Essential Oil,Peppermint Essential Oil,Ginger Essential Oil and Sweet Marjoram Essential Oil.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

It is used for smokers to quit smoking

Section 55106-9 (55106-9)

Nicotine

Advanced Ingredient Data

[{"name": "NICOTINE", "unii": "6M3C89ZY6R", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PEPPERMINT", "unii": "V95R5KMY2B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CLOVE OIL", "unii": "578389D6D0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STAR ANISE OIL", "unii": "6RXP35EIRE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GINGER OIL", "unii": "SAS9Z1SVUK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SWEET MARJORAM OIL", "unii": "ICH7BE016E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Apply one patch every 24 hours to clean,dry,hairless skin.Remove backing and apply immediately.Press firmly for 10 seconds. Wash hands after applying or removing.Fold used patch with sticky sides together and place in pouch for disposal.Change application site daily to avoid skin irritation.", "34068-7": "Use one 21 mg Patch/day Use one 14 mg Patch/day Use one 7 mg Patch/day", "34071-1": "if you are pregnant or breastfeeding,use this product only under the supervision of a healthcare professional,Smoking poses serious risks to your baby.", "50565-1": "KEEP OUT OF REACH OF CHILDREN AND PETS", "51727-6": "Clove Essential Oil,Star Anise Essential Oil,Sweet Orange Essential Oil,Peppermint Essential Oil,Ginger Essential Oil and Sweet Marjoram Essential Oil.", "55105-1": "It is used for smokers to quit smoking", "55106-9": "Nicotine"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:06.065475 · Updated: 2026-03-14T23:17:29.613906