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Ammonia Inhalants

AMMONIA INHALANTS

Approved
Approval ID

4cc59056-a5a8-696d-e054-00144ff88e88

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 4, 2019

Manufacturers
FDA

Sina Health Inc

DUNS: 047161553

Products 1

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

Ammonia Inhalants

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70385-2003
Product Classification
G
Generic Name
Ammonia Inhalants
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateFebruary 4, 2019
FDA Product Classification

INGREDIENTS (7)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
LAVENDER OILInactive
Code: ZBP1YXW0H8
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEMON OILInactive
Code: I9GRO824LL
Classification: IACT
NUTMEG OILInactive
Code: Z1CLM48948
Classification: IACT
AMMONIAActive
Quantity: 0.045 g in 0.3 mL
Code: 5138Q19F1X
Classification: ACTIB

Drug Labeling Information

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/28/2012

Active ingredient(s)

Ammonia (15%)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/28/2012

Inactive ingredients

Alcohol USP, FDC red dye 40, lavender oil fcc, lemon oil fcc, nutmeg oil fcc, purified water usp

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/28/2012

Questions

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Ammonia Inhalants - FDA Drug Approval Details