Label: BURN GEL 01 (melaleuca alternifolia- tea tree leaf oil gel

  • NDC Code(s): 82953-045-01
  • Packager: Cosmuses Cosmetics (Ningbo) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 6, 2025

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

View All Sections
  • SPL UNCLASSIFIED SECTION
    Drug Facts
  • Active ingredients
    melaleuca alternifolia (tea tree) leaf oil 1%
  • Purpose
    antibacterial and soothing
  • Uses
    Temporary soothes aches and pains associated with minor burn
  • warnings
    For external use only.
  • ENVIRONMENTAL WARNING
    Flammable: keep away from excessice heat or open flame.
  • ASK DOCTOR
    Ask a doctor before use if you have: sensitive skin
  • WHEN USING
    When using this product: Avoid contact with eyes and mucous membranes. Do no apply to wounds or damaged skin. Do not use with other ointments, creams, sprays or liniments. Do not apply to ...
  • STOP USE
    Stop use and ask a doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.
  • PREGNANCY OR BREAST FEEDING
    If pregnant or breast-feeding: ask a health professional before use.
  • KEEP OUT OF REACH OF CHILDREN
    Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately.
  • Directions
    Adults & children over 2 years of age: rub a thnk film over affected areas no more than 4 times a day- massage not necessary - Children under 2 years of age: consult physician.
  • other information
    Store in a cool dry place with lid closed tightly.
  • Inactive ingredients
    Aqua, Aloe Barbadensis Leaf Extract, PEG-40 Hydrogenated Castor Oil, Glycerin, Phenoxyethanol, Carbomer, Xanthan Gum, Triethanolamine.
  • PRINCIPAL DISPLAY PANEL
    82953-045
  • INGREDIENTS AND APPEARANCE
    Product Information
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!