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NDC 00395-0073-92 Humco Aromatic Ammonia Spirit 20 mg/mL Details

Humco Aromatic Ammonia Spirit 20 mg/mL

Humco Aromatic Ammonia Spirit is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Humco Holding Group, Inc.. The primary component is AMMONIA.

Product Information

NDC	00395-0073
Product ID	0395-0073_da6eaf23-7416-4307-e053-2995a90a142a
Associated GPIs	99000015109200
GCN Sequence Number	003541
GCN Sequence Number Description	ammonia SPIRIT INHALATION
HIC3	H2A
HIC3 Description	CENTRAL NERVOUS SYSTEM STIMULANTS
GCN	12590
HICL Sequence Number	001545
HICL Sequence Number Description	AMMONIA
Brand/Generic	Generic
Proprietary Name	Humco Aromatic Ammonia Spirit
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ammonia 2%
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	20
Active Ingredient Units	mg/mL
Substance Name	AMMONIA
Labeler Name	Humco Holding Group, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	n/a

Package

Package Images

NDC 00395-0073-92 (00395007392)

Pricing Information	N/A
NDC Package Code	0395-0073-92
Billing NDC	00395007392
Package	59 mL in 1 BOTTLE, PLASTIC (0395-0073-92)
Marketing Start Date	2008-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b3da9be3-0cd1-4a54-b885-33932f75700b Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Ammonia 2 %

Purpose

Respiratory Stimulant

Use

Respiratory stimulant used as a smelling salts to treat or prevent fainting.

Warnings

For external use only. Avoid eye contact with liquid vapors. Avoid inhaling more than a slight whiff. May cause irritation if excess is inhaled.

If pregnant or nursing a baby

seek the advice of a doctor before using this product.

Keep out of the reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Directions

Inhale a slight whiff to treat a "fainting spell"

Inactive Ingredients

Ammonium Carbonate, Ethyl Alcohol 65%, Lavender Oil, Lemon Oil Terpenless, Myristica Oil and Purified Water.

Other Information

Flammable: Keep away from spark, heat or flame. Keep tightly closed at room temperature not to exceed 30C (86F).

Questions or Comments?

1-800-662-3435

Label

INGREDIENTS AND APPEARANCE

HUMCO AROMATIC AMMONIA SPIRIT

ammonia 2% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0395-0073
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X)	AMMONIA	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
AMMONIUM CARBONATE (UNII: NJ5VT0FKLJ)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LEMON OIL, TERPENELESS (UNII: X69W83NI7V)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0395-0073-92	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		01/01/2008	05/31/2025

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Humco Holding Group, Inc. (825672884)

Name	Address	ID/FEI	Business Operations
Establishment
Humco Holding Group, Inc.		825672884	manufacture(0395-0073) , analysis(0395-0073) , pack(0395-0073) , label(0395-0073)

Revised: 3/2022

Document Id: da6eaf23-7416-4307-e053-2995a90a142a

Set id: b3da9be3-0cd1-4a54-b885-33932f75700b

Version: 4

Effective Time: 20220317