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Frankincense - Medication Information

Product NDC Code 83872-338
Drug Name

Frankincense

Type Brand
Active Ingredients
Frankincense 30 g/30ml
Route TOPICAL
Dosage Form LIQUID
Application Number 505G(a)(3)
Labeler Name Shenzhen Xiaomai Manufacturing Co., Ltd.
Packages
Package NDC Code Description
83872-338-01 30 ml in 1 bottle, unit-dose (83872-338-01)
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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