Burn Gel

Burn Gel
SPL v1
SPL
SPL Set ID 3227bdc9-9323-68eb-e063-6294a90a29d2
Route
TOPICAL
Published
Effective Date 2025-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tea Tree Oil (1 g)
Inactive Ingredients
Phenoxyethanol Glycerin Carbomer 940 Aloe Barbadensis Leaf Water Xanthan Gum Peg-40 Hydrogenated Castor Oil Triethanolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-06

Description

Drug Facts

Purpose

antibacterial and soothing


Medication Information

Purpose

antibacterial and soothing

Description

Drug Facts

Uses

Temporary soothes aches and pains associated with minor burn

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if:

Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.

Section 50567-7

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.

Section 50569-3

Ask a doctor before use if you have: sensitive skin

Section 50742-6

Flammable: keep away from excessice heat or open flame.

Section 51945-4

Section 53414-9

If pregnant or breast-feeding: ask a health professional before use.

Warnings

For external use only.

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.

Active Ingredients

melaleuca alternifolia (tea tree) leaf oil 1%

Inactive Ingredients

Aqua, Aloe Barbadensis Leaf Extract, PEG-40 Hydrogenated Castor Oil, Glycerin, Phenoxyethanol, Carbomer, Xanthan Gum, Triethanolamine.


Structured Label Content

Uses

Temporary soothes aches and pains associated with minor burn

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.

Section 50567-7 (50567-7)

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.

Section 50569-3 (50569-3)

Ask a doctor before use if you have: sensitive skin

Section 50742-6 (50742-6)

Flammable: keep away from excessice heat or open flame.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding: ask a health professional before use.

Purpose

antibacterial and soothing

Warnings (warnings)

For external use only.

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 (other information)

Store in a cool dry place with lid closed tightly.

Active Ingredients (Active ingredients)

melaleuca alternifolia (tea tree) leaf oil 1%

Inactive Ingredients (Inactive ingredients)

Aqua, Aloe Barbadensis Leaf Extract, PEG-40 Hydrogenated Castor Oil, Glycerin, Phenoxyethanol, Carbomer, Xanthan Gum, Triethanolamine.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)