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| Product NDC Code | 76348-804 | ||||
|---|---|---|---|---|---|
| Drug Name | Healing tree calming anti-itch |
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| Type | Brand | ||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part348 | ||||
| Labeler Name | Renu Laboratories, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.1 Percent Hydrocortisone
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.Directions adults and children 2 years of age and older: spray affected area not more than 3 to 4 times daily children under 2 years of age: do not use consult a doctor to apply to face, spray into palm of hand and gently apply
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Aloe Barbadensis leaf juice (Aloe Vera), Arnica Montana Extract, Calendula Officinalis Extract (Calendula), Carbomer, Cetyl Alcohol, Commiphora Myrrha Oil (Myrrh), Deionized Water, Glycerin, Glycerol Stearate,Hydrastis Canadensis Root Extract (Goldenseal), Melaleuca Alternifolia Leaf Oil (Tea Tree), Mentha Piperita Oil (Peppermint), Olea Europaea Oil (Olive), PEG-120 Methyl Glucose Dioleate, Persea Gratissima Oil (Avocado), Polysorbate 20, Potassium Sorbate, Simmondsia Chinensis Oil (Jojoba), Sodium Benzoate, Symphytum Officinale Extract (Comfrey) Leaf, Triethanolamine.
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.Uses For the temporary relief and aid in reducing redness, itching and irritation associated with eczema, psoriasis, poison oak and ivy, bug bites, rashes, minor burns, abrasions and blemishes
Purpose
Information about the drug product’s indications for use.Anti-itch Anti-inflammatory
Spl product data elements
Usually a list of ingredients in a drug product.HEALING TREE CALMING ANTI-ITCH Hydrocortisone MYRRH OIL CETYL ALCOHOL GLYCERYL MONOSTEARATE MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL PEPPERMINT OIL HYDROCORTISONE HYDROCORTISONE JOJOBA OIL PEG-120 METHYL GLUCOSE DIOLEATE WATER AVOCADO OIL OLIVE OIL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE GLYCERIN CALENDULA OFFICINALIS FLOWER ALOE VERA LEAF POLYSORBATE 20 GOLDENSEAL COMFREY SODIUM BENZOATE TROLAMINE ARNICA MONTANA FLOWER POTASSIUM SORBATE
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.Multi-layer Label Healing Tree Anti-Itch Cream ANTI-ITCH CREAM LABEL
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use for external genital, vaginal or anal itching with other hydrocortisone product unless consulted by a doctor in or near the eyes for diaper rash
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 Poison Control Center right away
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? call 800-376-1293 Manufactured for Healing Tree Essentials Yamhill, OR 97148 healingtreenaturals.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 20° to 25° C (68° to 77° F)
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.For external use only
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