Controlling balm with tea tree oil

Manufacturer
CA-BOTANA INTERNATIONAL | RODOLFO UGELSTAD
Effective date
2025-07-02
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
legacy-cache
Hydrated at
2026-08-01 20:36:15

Label at a glance#

ProductControlling balm with tea tree oil
Active ingredientSALICYLIC ACID
Label structure7 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

Warnings:

For external use only.
Do not use on wounds or damaged skin
When using this product: use only as directed. Avoid contact with eyes. Do no bandage tightly
Stop use and ask a doctor if: redness is present. Irritation develops. Condition worsens or symptoms persist more than 7 days. Symptoms clear up and occur again within a few days.
Store at room temperature. Lot number and expiration date see crimp or see box.

DOSAGE & ADMINISTRATION SECTION

cleanse the skin thoroughly with soft foam deep cleanse before applying. cover the entire affected aread with a thin layer 1 to 2 times daily. because too much drying of the skin may occure, start with 1 application daily, then gradually increase to 2 times daily if needed or as directed by a doctor. if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

INACTIVE INGREDIENT SECTION

Acrilates/Acrylamine Copolymer
Aloe barbadensis (Aloe vera) extract
Alpha Copper Tripeptide-4 TM
Argania Spinosa (Argan) extract
Benzyl Alcohol
Camellia sinensis (White tea) extract
Chamomilla recutita (Chamomile) extract
Cinnamomum Zeylanicum
Citrus medica lemonum (Lemon)Peel Oil
Copper Gluconate
Ethanol
Ethylhexylglycerin
Euterpe oleracea (Acai) extract
Gingko Biloba extract
Glycine
Hamamelis virginiana (Witchhazel) extract
Hypericum perforatum (St John's wort) extract
Juniperus communis (Juniper) extract
Lactic acid
Lavandula angustifolia oil
Malpighia glabra (Acerola) extract
Melaleuca Alternifolia (Tea tree) leaf oil
Olea europaea (Olive) leaf extract
Phenoxyethanol
Phosphatidylcholine
Pinus Taeda (Pine tree) extract
Polysorbate 20
Potassium Sorbate
Propanediol
Punica granatum (Pomegranate) extract
Rosa canina extract
Rosmarinus officinalis (Rosemary) extract
Sodium Hyaluronate
Sodium Hydroxide
Sodium PC
Tetra sodium
Vitis Vinifera ( Grape) extract
Water (Aqua)
Xanthan Gum

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact a Posion Control Center immediately.

INDICATIONS & USAGE SECTION

Enter section text here

OTC - PURPOSE SECTION

Enter section text here

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


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DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
.ALPHA.,.ALPHA.-DIMETHYLBENZYL ALCOHOLINACTIVE INGREDIENTJE030BGE051
1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINEINACTIVE INGREDIENTH026DM5V6U1
ACAIINACTIVE INGREDIENT46AM2VJ0AW1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ARGANIA SPINOSA LEAFINACTIVE INGREDIENT51XV5WTF7E1
CAMELLIA SINENSIS FLOWERINACTIVE INGREDIENT9I2BJY2J171
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X1
CINNAMONINACTIVE INGREDIENT5S29HWU6QB1
COPPERINACTIVE INGREDIENT789U1901C51
COPPER GLUCONATEINACTIVE INGREDIENTRV823G6G671
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
GINKGOINACTIVE INGREDIENT19FUJ2C58T1
GLATIRAMER ACETATEINACTIVE INGREDIENT5M691HL4BO1
GLYCINEINACTIVE INGREDIENTTE7660XO1C1
HAMAMELIS VIRGINIANA BARKINACTIVE INGREDIENTIH3063S9MY1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
HYPERICUM PERFORATUMINACTIVE INGREDIENTXK4IUX8MNB1
JUNIPERUS COMMUNIS FRUITINACTIVE INGREDIENTO84B5194RL1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5AT1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H81
LEMON OILINACTIVE INGREDIENTI9GRO824LL1
MALPIGHIA EMARGINATA SEEDINACTIVE INGREDIENT1X7L93686M1
MELALEUCA ALTERNIFOLIA LEAFINACTIVE INGREDIENTG43C57162K1
OLEA EUROPAEA LEAFINACTIVE INGREDIENTMJ95C3OH471
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PINUS TAEDA BARKINACTIVE INGREDIENT9I1F994SVG1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
PROPYLENE GLYCOL, (R)-INACTIVE INGREDIENT602HN5L69H1
PUNICA GRANATUM FLOWERINACTIVE INGREDIENTD9B634V4GP1
ROSA CANINA FLOWERINACTIVE INGREDIENT81MCR2UQ6Q1
ROSEMARYINACTIVE INGREDIENTIJ67X351P91
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A21
VITIS VINIFERA FLOWERING TOPINACTIVE INGREDIENT6TG3V35HTV1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35192-01635192-016-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 368 matching rows.

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1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINEH026DM5V6UINJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL8 mgExact identifier — unii candidate
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openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4b343bb7-6c9b-bd20-e063-6394a90a162c2bc24434-cfd4-4e88-8148-1067b3cbc6db2026-02-19WarningsExact identifier
spl set id: 2bc24434-cfd4-4e88-8148-1067b3cbc6db

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.