Label: TETRI-AG- tetracaine ointment

  • NDC Code(s): 83035-7120-3
  • Packager: Singular Dreamer, Ltd dba True Marker
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 30, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredient   Purpose

    Tetracaine 1.9%.       Topical Analgesic

  • PURPOSE

  • Use

    For the temporary relief of: Pain, associated with

    • Minor burns 
    • Minor cuts 
    • Scrapes 
    • Sunburn
  • Warnings

    For external use only.

    Do not use

    • in large quantities 
    • over raw surfaces 
    • blistered areas 
    • on wounds or damaged skin 
    • with a heating pad 
    • if you are allergic to any ingredients of this product

    When using this product

    • use only as directed 
    • avoid contact with the eyes, mucous membranes or rashes 
    • do not bandage tightly

    Stop use and ask a doctor if:

    • symptoms persist for more than 7 days 
    • symptoms clear up and occur again within a few days 
    • skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, and blistering 
    • conditions worsen

    If pregnant or breast feeding, ask health professional before use.

    Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center (-1800-222-1222) right away.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions:

    Adults and children 2 years of age and older:

    • Apply to affected area not more than 3 to 4 times daily.


    Children under 2 years of age:

    • do not use, consult a doctor.
  • Other Information:

    Store at 20-25 C (68-77F). [see USP Controlled Room Temperature].

  • Inactive Ingredients:

    Aqua (Deionized Water), Methylisothiazolinone, PEG-8, PEG-8 Stearate, PEG-100 Stearate, Polyethylene Glycol

  • Questions or comments?

    Call 1-888-811-2634

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    TETRI-AG 
    tetracaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83035-7120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV) TETRACAINE1.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PEG-8 STEARATE (UNII: 2P9L47VI5E)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83035-7120-31 in 1 BOTTLE01/24/2024
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/24/2024
    Labeler - Singular Dreamer, Ltd dba True Marker (129504103)
    Registrant - Singular Dreamer, Ltd dba True Marker (129504103)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!