Label: GO TIME - ammonia inhalant
- NDC Code(s): 53063-1112-1, 53063-1112-2
- Packager: Mountain Top Labs, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (each inhalant)
To arouse consciousness and restore mental alertness.Close
For external use only
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Hold inhalant away from face and crush between thumb and forefinger. Carefully approach crushed inhalant to nostril until desired effect is achieved.Close
- Other information
Store at room temperature away from light.Close
- Inactive ingredients
Alcohol USP, Eucalyptus Oil, FD and C Blue Dye #1, Lemon Oil, Purified Water USP, Rosemary OilClose
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53063-1112 Route of Administration RESPIRATORY (INHALATION) DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMMONIA (AMMONIA) AMMONIA 0.013 mL in 0.3 mL Inactive Ingredients Ingredient Name Strength ALCOHOL EUCALYPTUS OIL FD&C BLUE NO. 1 LEMON OIL WATER ROSEMARY OIL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53063-1112-2 4 in 1 BOX 1 NDC:53063-1112-1 0.3 mL in 1 AMPULE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/13/2012 Labeler - Mountain Top Labs, LLC (078408468) Establishment Name Address ID/FEI Business Operations Omniglow de Mexico, S.A. de C .V. 589918408 manufacture(53063-1112)