85590-003

85590-003
SPL v1
SPL
SPL Set ID 3e7e4c2c-08bc-37b7-e063-6394a90a6b21
Route
TOPICAL
Published
Effective Date 2025-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-11

Description

Ammonia 15%

Purpose

Inhalants


Medication Information

Purpose

Inhalants

Description

Ammonia 15%

Use

To prevent or treat fainting

Stop Use

Stop use and ask a doctor if allergic reaction(rash,swelling) or persistent irritation occurs.

Warnings

For external use only.

Ask Doctor

Stop use and ask a doctor if allergic reaction(rash,swelling) or persistent irritation occurs.

Directions

Hold bottle 10-15cm from nostrils and inhale slowly 1-2 times.

Do Not Use

DO NOT USE if you have respiratory conditions such as asthma or emphysema.Discontinue use and consult a doctor if symptoms persist.

When Using

Avoid repeated inhalation.Do not use more than 2 times per application.

Active Ingredient

Ammonia 15%

Other Information

Store in a dark, dry place at 15-25°C

Inactive Ingredients

Alcohol,Cotton,Peppermint Flavor

Principal Display Panel

Keep Out of Reach of Children

Store in a cool,dry place inaccessible to children. Swallowing my cause poisoning. If swallowed, seek immediate medical assistance or contact a Poison Control Center(1-800-222-1222).


Structured Label Content

Use

To prevent or treat fainting

Purpose

Inhalants

Stop Use

Stop use and ask a doctor if allergic reaction(rash,swelling) or persistent irritation occurs.

Warnings

For external use only.

Ask Doctor

Stop use and ask a doctor if allergic reaction(rash,swelling) or persistent irritation occurs.

Directions

Hold bottle 10-15cm from nostrils and inhale slowly 1-2 times.

Do Not Use (Do not use)

DO NOT USE if you have respiratory conditions such as asthma or emphysema.Discontinue use and consult a doctor if symptoms persist.

When Using

Avoid repeated inhalation.Do not use more than 2 times per application.

Active Ingredient

Ammonia 15%

Other Information (Other information)

Store in a dark, dry place at 15-25°C

Inactive Ingredients (Inactive ingredients)

Alcohol,Cotton,Peppermint Flavor

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Store in a cool,dry place inaccessible to children. Swallowing my cause poisoning. If swallowed, seek immediate medical assistance or contact a Poison Control Center(1-800-222-1222).


Advanced Ingredient Data


Raw Label Data

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