36a428a9-4549-bbd4-e063-6294a90ae783

SPL v1
SPL
SPL Set ID 36a428a9-4549-bbd4-e063-6294a90ae783
Route
nasal
Published
Effective Date 2025-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
ammonia (29 g)
Inactive Ingredients
peppermint oil sodium polyacrylate (8000 mw)

Identifiers & Packaging

Marketing Status
unapproved drug other active Since 2025-04-01

Description

Aqueous ammonia (29%)


Medication Information

Warnings and Precautions
  • Temporary burning, stinging or eye watering may occur.
  • For external use only. Flammable: keep away from fire or flame.
  • Do not use if allergic to any of the ingredients.
  • Not recommended for use to revive people after injuries to the head or brain.
  • This product has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease
Active Ingredient

Aqueous ammonia (29%)

Indications and Usage

Respitory stimulant. For inhalation only. Use responsibly and in moderation.

Best used within 30 days after opening. Store in a cool, dry place

Dosage and Administration
  • Hold 2-3 inches below nose
  • Squeeze & inhale
Description

Aqueous ammonia (29%)

Section 50565-1

Keep out of reach of small children.

Section 51727-6

Peppermint essential oil, sodium polyacrylate

Section 51945-4

Section 53414-9

If pregnant, breastfeeding or at risk of any underlying respiratory conditions, ask a healthcare professional before use.

Section 55105-1

Reflex stimulant


Structured Label Content

Warnings and Precautions (34071-1)
  • Temporary burning, stinging or eye watering may occur.
  • For external use only. Flammable: keep away from fire or flame.
  • Do not use if allergic to any of the ingredients.
  • Not recommended for use to revive people after injuries to the head or brain.
  • This product has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease
Active Ingredient (55106-9)

Aqueous ammonia (29%)

Indications and Usage (34067-9)

Respitory stimulant. For inhalation only. Use responsibly and in moderation.

Best used within 30 days after opening. Store in a cool, dry place

Dosage and Administration (34068-7)
  • Hold 2-3 inches below nose
  • Squeeze & inhale
Section 50565-1 (50565-1)

Keep out of reach of small children.

Section 51727-6 (51727-6)

Peppermint essential oil, sodium polyacrylate

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant, breastfeeding or at risk of any underlying respiratory conditions, ask a healthcare professional before use.

Section 55105-1 (55105-1)

Reflex stimulant


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)