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Drug Facts
Burn Gel
FDA Label NDC 82953-045
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmuses Cosmetics (ningbo) Co., Ltd. for the product Burn Gel (NDC 82953-045). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, environmental warning, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
