Country: United States
Language: English
Source: NLM (National Library of Medicine)
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X)
AmmoniaSport LLC
TOPICAL
OTC DRUG
Respiratory Stimulant Respiratory stimulant used as a smelling salts to treat or prevent fainting.
unapproved drug other
AMMONIASPORT SQUEEZE- AMMONIA 2% LIQUID AMMONIASPORT LLC _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._ ---------- AMMONIASPORT SQUEEZE Drug Facts ACTIVE INGREDIENT Ammonia 0.3% PURPOS E Respiratory Stimulant US E 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 Water, Sodium Carbonate 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 31 ml NDC 73395-198 AMMONIASPORT SQUEEZE ammonia 2% liquid PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:7339 5-19 8 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH AMMO NIA (UNII: 5138 Q19 F1X) (AMMONIA - UNII:5138 Q19 F1X) AMMONIA 7 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) SO DIUM CARBO NATE (UNII: 45P326 1C7T) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:7339 5-19 8 - 0 1 31 mL in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n Pro duc t 0 9 /0 1/20 20 AmmoniaSport LLC MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE unappro ved drug o ther 0 9 /0 1/20 20 LABELER - AmmoniaSport LLC (048476710) REGISTRANT - AmmoniaSport LLC (048476710) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS Read the complete document