SPL v1
SPL
SPL Set ID 3a1cc0e1-fabf-52b9-e063-6394a90ae35e
Route
TOPICAL
Published
Effective Date 2025-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (21 mg)
Inactive Ingredients
Ethylene-vinyl Acetate Copolymer (19% Vinylacetate) Petroselinic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-17

Description

menthol


Medication Information

Warnings and Precautions

If you are pregnant or breast-feeding, only use this medicine on the advice of your healthcare provider.Smoking can seriously harm your child.Try to stop smoking without using any nicotine replacement medicine.This medicine is believed to safer than smoking.However, the risks to your child from this medicine are not full known.

Indications and Usage

ifyou smoke 10 orless cigarettes per day, do not useSTEP 1 (21 mg). Start with STEP 2 (14 mg) for 6 weeks,then STEP 3 (7 mg) for 2 weeks and then stop.steps 2 and 3 allow you to gradually reduce yourlevel ofnicotine.Completingthe full program willincrease yourchances ofquittingsuccessfully.apply one new patch every 24 hours on skin that is dry, cleanand hairless. Save pouch for disposingofthe patch after use.remove backingfrom patch andimmediately press onto skin.Hold for 10 seconds.

Dosage and Administration

STEP1

Use one 21 mgpatch/day

Weeks 1-6

STEP 2

Use one 14 mg

patch/day

Weeks 7-8

STEP 3

Use one7mg

patch/day

Weeks9-10

Description

menthol

Section 50565-1

Keep out of reach of children and pets.

Used patches have enough nicotine to poison children and pets.If swallowed, get medical help or contact a Poison Control Center right away.Save pouch to use for patch di posal.Dispose of the used patches by folding sticky ends together and putting in pouch.

Section 50567-7

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Section 50569-3

Ask a doctor or pharmacist before use ifyou are"usinga non-nicotine stop smoking drugtaking a prescription medicine for depression or asthma.Your prescription dose may need to be adjusted.

Section 51727-6

nactive ingredientsethylene vinylacetate-copolymer, polyisobutylene and high densitypolyethylene between clearpolyester backings

Section 51945-4

Section 55105-1

Stop smoking aid

Section 55106-9

menthol


Structured Label Content

Indications and Usage (34067-9)

ifyou smoke 10 orless cigarettes per day, do not useSTEP 1 (21 mg). Start with STEP 2 (14 mg) for 6 weeks,then STEP 3 (7 mg) for 2 weeks and then stop.steps 2 and 3 allow you to gradually reduce yourlevel ofnicotine.Completingthe full program willincrease yourchances ofquittingsuccessfully.apply one new patch every 24 hours on skin that is dry, cleanand hairless. Save pouch for disposingofthe patch after use.remove backingfrom patch andimmediately press onto skin.Hold for 10 seconds.

Dosage and Administration (34068-7)

STEP1

Use one 21 mgpatch/day

Weeks 1-6

STEP 2

Use one 14 mg

patch/day

Weeks 7-8

STEP 3

Use one7mg

patch/day

Weeks9-10

Warnings and Precautions (34071-1)

If you are pregnant or breast-feeding, only use this medicine on the advice of your healthcare provider.Smoking can seriously harm your child.Try to stop smoking without using any nicotine replacement medicine.This medicine is believed to safer than smoking.However, the risks to your child from this medicine are not full known.

Section 50565-1 (50565-1)

Keep out of reach of children and pets.

Used patches have enough nicotine to poison children and pets.If swallowed, get medical help or contact a Poison Control Center right away.Save pouch to use for patch di posal.Dispose of the used patches by folding sticky ends together and putting in pouch.

Section 50567-7 (50567-7)

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Section 50569-3 (50569-3)

Ask a doctor or pharmacist before use ifyou are"usinga non-nicotine stop smoking drugtaking a prescription medicine for depression or asthma.Your prescription dose may need to be adjusted.

Section 51727-6 (51727-6)

nactive ingredientsethylene vinylacetate-copolymer, polyisobutylene and high densitypolyethylene between clearpolyester backings

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Stop smoking aid

Section 55106-9 (55106-9)

menthol


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)