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| Product NDC Code | 35192-016 | ||||
|---|---|---|---|---|---|
| Drug Name | Controlling balm with tea tree oil |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | EMULSION | ||||
| Application Number | M006 | ||||
| Labeler Name | CA-BOTANA INTERNATIONAL | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
A list of inactive, non-medicinal ingredients in a drug product.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
| 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 |
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Enter section text here
Purpose
Information about the drug product’s indications for use.Enter section text here
Spl product data elements
Usually a list of ingredients in a drug product.Controlling balm with tea tree oil SALICYLIC ACID ROSA CANINA FLOWER ROSEMARY SODIUM HYDROXIDE VITIS VINIFERA FLOWERING TOP WATER XANTHAN GUM SODIUM PYRROLIDONE CARBOXYLATE HYALURONATE SODIUM PROPYLENE GLYCOL, (R)- 1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE SALICYLIC ACID SALICYLIC ACID GLATIRAMER ACETATE ALOE VERA LEAF COPPER ARGANIA SPINOSA LEAF .ALPHA.,.ALPHA.-DIMETHYLBENZYL ALCOHOL CAMELLIA SINENSIS FLOWER CHAMOMILE CINNAMON LEMON OIL COPPER GLUCONATE ALCOHOL ETHYLHEXYLGLYCERIN ACAI GINKGO GLYCINE HAMAMELIS VIRGINIANA BARK HYPERICUM PERFORATUM JUNIPER BERRY OIL LACTIC ACID LAVENDER OIL MALPIGHIA EMARGINATA SEED MELALEUCA ALTERNIFOLIA LEAF OLEA EUROPAEA LEAF PHENOXYETHANOL PINUS TAEDA BARK POLYSORBATE 20 POTASSIUM SORBATE PUNICA GRANATUM FLOWER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.image1 image2
Package Label Display Panel
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed get medical help or contact a Posion Control Center immediately.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API