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| Product NDC Code | 83872-338 | ||||
|---|---|---|---|---|---|
| Drug Name | Frankincense |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Shenzhen Xiaomai Manufacturing Co., Ltd. | ||||
| 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.Active Ingredient FRANKINCENSE 100%
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 1. Apply 1 ML(few drops) directly onto scalpon the hairloss area. 2. Use fingertips to massage solution intoskin/hair for2-3 minutes. 3. Allow time for hair to fully absorb GrowthOil For bestresults, use twice daily onclean dry hair.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients FRANKINCENSE,Water
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.Use DISPENSE A SMALL AMOUNT INTO PALMS, RUB HANDS TOGETHER TOABSORB INTO SKIN
Purpose
Information about the drug product’s indications for use.Purpose DISPENSE A SMALL AMOUNT INTO PALMS, RUB HANDS TOGETHER TOABSORB INTO SKIN
Spl product data elements
Usually a list of ingredients in a drug product.Frankincense oil FRANKINCENSE FRANKINCENSE WATER
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.PRINCIPAL DISPLAY PANEL LBEAL
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.Ask Doctor When Pregnant or breast-feeding.
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 READ LABEL BEFORE USEDO A SKIN PATCH TESTUSE WITH CAUTION IF PREGNANT OR NURSINGCHILDREN NEED ADULT SUPERVISIONAVOID EYE AND MOUTH CONTACTFINISH WITHIN 6 MONTHS AFTER OPENING
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 Oot Of Reach Of Children Keep Out Of Reach Of Chlidren
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 chest pain, rapid heart beat.faintness, or dizziness occurs sudden, unexplained weight gain occurs. your hands or feet swell scalp imitation or redness occurs May be harmful if used when pregnant or breast-feeding Keep Out Of Reach Of Chlidren: if swallowed,get medical help or contact a Poison Control Center right away.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When Using DISPENSE A SMALL AMOUNT INTO PALMS, RUB HANDS TOGETHER TOABSORB INTO SKIN. CAN APPLY DIRECTLY OR MIX WTTH SKINCARE PRODUCTS ORMASSAGE OILS. AVOID CONTACT WTTH EYES, NOSE, MOUTH AND OTHER SENSITTVE AREAS. USE 1-2 TIMES DAILY, ADJUST AMOUNT AS NEEDED. SEAL BOTTLE AFTER USE, STORE IN A COOL DRY PLACE.
Storage and handling
Information about safe storage and handling of the drug product.Other information Before use, read all information on thecarton Store at controlled room temperature20 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.Warnings -For external use only -Keep away from fire and flame
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