85765-003 Smelling Salts

85765-003 Smelling Salts
SPL v4
SPL
SPL Set ID 38c57576-e2c1-c447-e063-6394a90a62ae
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2025-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ammonia (0.15 g)
Inactive Ingredients
Alcohol Cotton Peppermint Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-30

Description

Ammonia 15%


Medication Information

Warnings and Precautions



ForinHalAtion use only.

Do notingest or apply to skin.

Avoid direct contact with eyes. lfcontact occurs, rinse thoroughly with water for l5 minutes.

Use only as directed. Misuse may be harmful.

Use in a well-ventilated area. Donot usein enclosed spaces.

Prolonged exposure may cause irritation. Discontinue use if discomfort occurs.

Possible side effectsinclude nasaliritation, coughing, or shortness of breath.lf symptoms persist, discontinue use and consult a doctor.

Indications and Usage

Forthe temporarystimulation of the senses to restore alertness

Dosage and Administration



Hold bottle 10-15 cm (4-6 inches) from nostrils.

Inhale gently.Do not place directlyinside the nostrils.

Do notinhale for more than 2 seconds per use.

Do not use more than once every 60 minutes.

Do not use more than 10 times per day.

Use only as needed.lfsymptoms persist,consult a healthcare professional.

Description

Ammonia 15%

Section 50565-1



Keep out ofreach ofchildren.lfswallowed, get medical

help or contacta Poison Control Centerimmediately at 1-800-222-1222

Section 50566-9

Stop use and ask a doctorifirritation orrash occursThese may be signs of a serious condition,

Section 50567-7



Avoid contact with eyes,ears, and mouth.

lf product gets into eyes, rinse thoroughly with water for 15minutes.

Stop use and ask a doctor ifirritation or rash occurs.

These may be signs of a serious condition.

Section 50570-1



lf you have respiratory conditions such as asthma oremphysemA.

lf you have heart disease or high blood pressure.

lf you are allergic to ammonia or strongodors.

Section 51727-6

Alcohol

Cotton

Peppermint Oil

Section 51945-4

Section 55105-1

Inhalant

Section 55106-9

Ammonia 15%


Structured Label Content

Indications and Usage (34067-9)

Forthe temporarystimulation of the senses to restore alertness

Dosage and Administration (34068-7)



Hold bottle 10-15 cm (4-6 inches) from nostrils.

Inhale gently.Do not place directlyinside the nostrils.

Do notinhale for more than 2 seconds per use.

Do not use more than once every 60 minutes.

Do not use more than 10 times per day.

Use only as needed.lfsymptoms persist,consult a healthcare professional.

Warnings and Precautions (34071-1)



ForinHalAtion use only.

Do notingest or apply to skin.

Avoid direct contact with eyes. lfcontact occurs, rinse thoroughly with water for l5 minutes.

Use only as directed. Misuse may be harmful.

Use in a well-ventilated area. Donot usein enclosed spaces.

Prolonged exposure may cause irritation. Discontinue use if discomfort occurs.

Possible side effectsinclude nasaliritation, coughing, or shortness of breath.lf symptoms persist, discontinue use and consult a doctor.

Section 50565-1 (50565-1)



Keep out ofreach ofchildren.lfswallowed, get medical

help or contacta Poison Control Centerimmediately at 1-800-222-1222

Section 50566-9 (50566-9)

Stop use and ask a doctorifirritation orrash occursThese may be signs of a serious condition,

Section 50567-7 (50567-7)



Avoid contact with eyes,ears, and mouth.

lf product gets into eyes, rinse thoroughly with water for 15minutes.

Stop use and ask a doctor ifirritation or rash occurs.

These may be signs of a serious condition.

Section 50570-1 (50570-1)



lf you have respiratory conditions such as asthma oremphysemA.

lf you have heart disease or high blood pressure.

lf you are allergic to ammonia or strongodors.

Section 51727-6 (51727-6)

Alcohol

Cotton

Peppermint Oil

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Inhalant

Section 55106-9 (55106-9)

Ammonia 15%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)