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FDA Approval

Shock-X Ammonia Inhalant

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
May 22, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Ammonia(15 g in 100 g)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Shock-X Ammonia Inhalant

Product Details

NDC Product Code
85570-1111
Application Number
505G(a)(3)
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
NASAL
Effective Date
May 22, 2025
SEA SALTInactive
Code: 87GE52P74GClass: IACT
PEPPERMINT OILInactive
Code: AV092KU4JHClass: IACT
AmmoniaActive
Code: 5138Q19F1XClass: ACTIBQuantity: 15 g in 100 g
AMMONIUM CARBONATEInactive
Code: NJ5VT0FKLJClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packaging

Label


INDICATIONS & USAGE SECTION

Uses

To prevent or treat fainting.

DOSAGE & ADMINISTRATION SECTION

Directions

Hold inhalant away from face and slowly approach inhalant to nostrils and inhale. Avoid contact with eyes and skin.


WARNINGS SECTION

Warnings

For external use only.

Do not use if you have breathing problems such as asthma or emphysema. Stop use and ask a doctor if condition persists.

Keep out of the reach of children.

If swallowed, seek medical help or contact a Poison Control Center right away.

If pregnant or nursing, seek the advice of a doctor before using this product.


OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Ammonia (15%)

OTC - PURPOSE SECTION

Purpose

Inhalant

OTC - QUESTIONS SECTION

Questions

Contact us at support@shock-x.com


OTHER SAFETY INFORMATION

Other Information

Store at room temperature away from light.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Alcohol, Cotton, Peppermint Oil, Water.


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