AROMATIC AMMONIA SPIRIT- ammonia 2% liquid 
Humco Holding Group, inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Private Label Aromatic Ammonia Spirit

 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

Label

AROMATIC AMMONIA SPIRIT 
ammonia 2% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AMMONIUM CARBONATE (UNII: NJ5VT0FKLJ)  
ALCOHOL (UNII: 3K9958V90M)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
LEMON OIL, TERPENELESS (UNII: X69W83NI7V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0395-9101-9259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/12/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/200810/31/2023
Labeler - Humco Holding Group, inc (825672884)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIBusiness Operations
Humco Holding Group, Inc.825672884manufacture(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
 
Humco Holding Group, inc