MedPath

Shock-X Ammonia Inhalant

Approved
Approval ID

3365af8c-78cb-4978-e063-6394a90a2e87

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 22, 2025

Manufacturers
FDA

Platinum Trident Enterprise

DUNS: 119491265

Products 1

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

Ammonia Inhalant

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85570-1111
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Ammonia Inhalant
Product Specifications
Route of AdministrationNASAL
Effective DateMay 22, 2025
FDA Product Classification

INGREDIENTS (4)

SEA SALTInactive
Code: 87GE52P74G
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
AMMONIAActive
Quantity: 15 g in 100 g
Code: 5138Q19F1X
Classification: ACTIB
AMMONIUM CARBONATEInactive
Code: NJ5VT0FKLJ
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/1/2025

Packaging

Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/1/2025

Uses

To prevent or treat fainting.

WARNINGS SECTION

LOINC: 34071-1Updated: 1/1/2025

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/1/2025

Directions

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

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 1/1/2025

Other Information

Store at room temperature away from light.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/1/2025

Inactive Ingredients

Alcohol, Cotton, Peppermint Oil, Water.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/1/2025

Questions

Contact us at support@shock-x.com

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/1/2025

Active Ingredients

Ammonia (15%)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/1/2025

Purpose

Inhalant

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Shock-X Ammonia Inhalant - FDA Drug Approval Details