85765-002 Smelling Salts

85765-002 Smelling Salts
SPL v4
SPL
SPL Set ID 38601f38-09ef-9bb2-e063-6294a90a83d6
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2025-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ammonia (15 g)
Inactive Ingredients
Peppermint Oil Cotton Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-06-25

Description

Ammonia 15%


Medication Information

Warnings and Precautions

For inHalAtion use only.

Avoid direct contact with eyes.lfcontact occurs,rinse thoroughly with water fori5 minutes.Use only as directed. Misuse may be harmful.

Use in a well-ventilated area.Do notuse in enclosedspaces

Prolonged exposure maycause irritation.Discantinue useifdiscomfort occurs.

Possible side effectsinclude nasallritation,coughing.or shortness of breath.lfsymptoms persist, discontinue use and consulta doctor

Indications and Usage

For the temporarystimulation ofthe senses to restore alertness.

Description

Ammonia 15%

Section 50565-1



Keep outofreach ofchildren.lfswallowed,get medical

help or contacta Poison control center immediately at 1-800-222-1222.

Section 50566-9



Stop use and ask a doctorifirritation or rash occurs.

These may be signs ofa serious condition.

Section 50567-7

Avoid contact with eyes,ears, and mouth.

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

Stop use and ask a doctorifirritation orrash occurs.

These may be signs ofaserious condition.

Section 50570-1

Do not ingest or apply to skin.

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)

For the temporarystimulation ofthe senses to restore alertness.

Warnings and Precautions (34071-1)

For inHalAtion use only.

Avoid direct contact with eyes.lfcontact occurs,rinse thoroughly with water fori5 minutes.Use only as directed. Misuse may be harmful.

Use in a well-ventilated area.Do notuse in enclosedspaces

Prolonged exposure maycause irritation.Discantinue useifdiscomfort occurs.

Possible side effectsinclude nasallritation,coughing.or shortness of breath.lfsymptoms persist, discontinue use and consulta doctor

Section 50565-1 (50565-1)



Keep outofreach ofchildren.lfswallowed,get medical

help or contacta Poison control center immediately at 1-800-222-1222.

Section 50566-9 (50566-9)



Stop use and ask a doctorifirritation or rash occurs.

These may be signs ofa serious condition.

Section 50567-7 (50567-7)

Avoid contact with eyes,ears, and mouth.

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

Stop use and ask a doctorifirritation orrash occurs.

These may be signs ofaserious condition.

Section 50570-1 (50570-1)

Do not ingest or apply to skin.

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

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