FDA Label for Burn Gel 01
View Indications, Usage & Precautions
Burn Gel 01 Product Label
The following document was submitted to the FDA by the labeler of this product Cosmuses Cosmetics (ningbo) Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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.
Otc - Ask Doctor
Ask a doctor before use if you have: sensitive skin
Otc - 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 irritated skin or if excessive irritation develops.
Do not bandage.
Wash hands after use with cool water.
Do not use with heating pad or device.
Otc - 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding: ask a health professional before use.
Otc - 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.
* Please review the disclaimer below.
