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NDC 00395-9101-92 Aromatic Ammonia Spirit 20 mg/mL Details

Aromatic Ammonia Spirit 20 mg/mL

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	00395-9101
Product ID	0395-9101_da6eac43-f418-8f1e-e053-2a95a90af4af
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	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 00395-9101-92 (00395910192)

Pricing Information	N/A
NDC Package Code	0395-9101-92
Billing NDC	00395910192
Package	59 mL in 1 BOTTLE, PLASTIC (0395-9101-92)
Marketing Start Date	2017-12-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 60402908-5519-5970-e053-2a91aa0ab361 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Ammonia 2 %

Purpose

Respiratory Stimulant

Indication

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 "faining spell"

Inactive Ingredients

Ammonium Carbonate, Ethyl Alcohol 656%, 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 toexceed 30C (86F).

Label

INGREDIENTS AND APPEARANCE

AROMATIC AMMONIA SPIRIT

ammonia 2% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0395-9101
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
AMMONIUM CARBONATE (UNII: NJ5VT0FKLJ)
ALCOHOL (UNII: 3K9958V90M)
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:0395-9101-92	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/12/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		01/01/2008	10/31/2023

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(0395-9101) , analysis(0395-9101) , pack(0395-9101) , label(0395-9101)

Revised: 3/2022

Document Id: da6eac43-f418-8f1e-e053-2a95a90af4af

Set id: 60402908-5519-5970-e053-2a91aa0ab361

Version: 4

Effective Time: 20220317