Tea tree oil

FDA Drug Profile — NAIL TREATMENT Oil Elixirs

Drug Details

Generic Name
Tea tree oil
Brand Names
NAIL TREATMENT Oil Elixirs
Application Number
505G(a)(3)
Sponsor
Guangzhou Mizi Biotechnology Co., LTD.
NDC Codes
1
Dosage Forms
LIQUID
Routes
TOPICAL
Active Ingredients
.ALPHA.-TOCOPHEROL, TEA TREE OIL

Indications and Usage

For effective treatment of most athlete's foot(tinea pedis), ringworm (tinea corporis) and jock itch(tinea cruris). For effective relief of itching, burning and cracking skin.

Warnings

For external use only. on children under 2 years of age unless directed by adoctor. When using this product avoid contact withthe eyes. Stop use and ask a doctor if irritationoccurs, there is no improvement within 4 weeks forathlete's foot or ringworm, there is no improvementwithin 2 weeks for jock itch. If swallowed, get medical help or contact aPoison Control Center right away.