melaleuca alternifolia (tea tree) leaf oil

FDA Drug Profile — burn gel 01

Drug Details

Generic Name
melaleuca alternifolia (tea tree) leaf oil
Brand Names
burn gel 01
Application Number
M004
Sponsor
Cosmuses Cosmetics (Ningbo) Co., Ltd.
NDC Codes
1
Dosage Forms
GEL
Routes
TOPICAL
Active Ingredients
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

Indications and Usage

Indications & Usage – Sea Jewels Lemon Balm Full Body Salve (0.5 oz) - Helps comfort skin during periods of irritation or flare-ups - Helps relieve symptoms associated with: • Cold sores and herpes outbreaks • Eczema and rashes • Ringworm and fungal irritation • Minor boils and abscesses • Insect bites • Shingles flare-ups • Minor burns See uploaded back label image. OTC Purpose Section 0.5oz Indications & Usage – Sea Jewels Lemon Balm Full Body Salve (4 oz) Helps comfort skin during periods of irritation or flare-ups Helps relieve symptoms associated with: • Cold sores and herpes outbreaks • Eczema and rashes • Ringworm and fungal irritation • Minor boils and abscesses • Insect bites • Shingles flare-ups • Minor burns See uploaded back label image. Indications & Usage – Sea Jewels Lemon Balm Full Body Salve (4 oz)

Warnings

Warnings – Sea Jewels Lemon Balm Full Body Salve (0.5 oz) For external use only See uploaded back label image. Warning Section 0.5oz Warnings – Sea Jewels Lemon Balm Full Body Salve (4 oz) For external use only See uploaded back label image. Warnings – Sea Jewels Lemon Balm Full Body Salve (4 oz) [WARNINGS SECTION]