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Tea tree - Medication Information

Product NDC Code 83872-282
Drug Name

Tea tree

Type Brand
Active Ingredients
Retinol 1 g/50ml
Tea tree oil 5 g/50ml
Route TOPICAL
Dosage Form CREAM
Application Number 505G(a)(3)
Labeler Name Shenzhen Xiaomai Manufacturing Co., Ltd.
Packages
Package NDC Code Description
83872-282-01 50 ml in 1 bottle, unit-dose (83872-282-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Retinol 1% Tea Tree oil 10%

Description

General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.
Do not use Do not use on damaged or broken skin

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. After cleansing the face, take an appropriate amount of spot lightening cream. 2. Apply evenly to the area on the face that needs to lighten spots, and massage gently until completely absorbed. 3. Use once in the morning and evening. Continuous use will provide better results.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Honey,Water,Squalane

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 Anti-wrinkle, moisturizes, nourishes and repairs skin, keeping skin hydrated, soft and smooth.

Purpose

Information about the drug product’s indications for use.
Purpose Anti-wrinkle, moisturizes

Spl product data elements

Usually a list of ingredients in a drug product.
TEA TREE Cream RETINOL RETINOL HONEY TEA TREE OIL TEA TREE OIL WATER SQUALANE

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.
LBEAL

Ask doctor or pharmacist

Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
Ask Doctor When Pregnant or breast-feeding.

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. Keep out of reach of children.If swallowed, get medical help or contacta Poison Control Center right away.

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 Stop use and ask a doctor if rash occurs

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 this product When using this product keep out of eyes. Rinse with water to remove.

Storage and handling

Information about safe storage and handling of the drug product.
Other information Please store in a cool, dry place away from direct sunlight.

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 damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children.If swallowed, get medical help or contacta Poison Control Center right away.

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