Label: ITSRT TEA TREE OIL AND ARGAN OIL emulsion

  • NDC Code(s): 84751-097-01
  • Packager: Guangzhou Qiaoyangzi Cosmetics Technology Co Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2024

If you are a consumer or patient please visit this version.

  • Active ingredients

    Glycerin 1.500%
    Aloe Barbadensis Leaf Water 1.000%
    Sorbic Acid 0.300%
    Rosmarinus Officinalis (Rosemary) Leaf Extract 0.09%
    Biotin 0.01%

  • INACTIVE INGREDIENT SECTION

    Aqua 71.650%
    Sodium Laureth Sulfate 8.300%
    Decyl Glucoside 2.000%
    Butylene Glycol 2.000%
    Sodium Chloride 1.750%
    Cetrimonium Chloride 1.650%
    Potassium Cocoate 1.500%
    Cocamidopropyl Betaine 1.500%
    Glycol Distearate 1.000%
    Silanetriol Arginate 1.000%
    Fragrance 0.500%
    Glycerol Formal 0.500%
    Glyceryl Stearate 0.500%
    Ethylhexylglycerin 0.500%
    Hydroxyacetophenone 0.350%
    Magnesium Chloride 0.100%
    Magnesium Nitrate 0.100%
    Glycyrrhiza Glabra Root Extract 0.30%
    Scutellaria Baicalensis Root Extract 0.30%
    Salicylic Acid 0.10%
    Melaleuca Alternifolia (Tea Tree) Leaf Oil 0.05%
    Centella Asiatica Extract 0.05%
    Polygonum Cuspidatum Root Extract 0.05%

  • Purpose

    Purpose:
    Cleansing: Removes dirt, oil, and buildup from hair and scalp.
    Moisturizing: Helps to hydrate and retain moisture in hair.
    Soothing: Relieves scalp irritation and discomfort.
    Antioxidant Protection: Provides protection against environmental damage.
    Promotes Hair Health: Strengthens and nourishes hair to promote healthy growth.
    Exfoliation: Helps to gently exfoliate the scalp to reduce flakiness and buildup.

  • Uses

    Indications & Usage:
    This shampoo is indicated for:

    Cleansing the hair and scalp: Effectively removes dirt, excess oil, and product buildup.
    Moisturizing and hydrating: Helps maintain the moisture balance of the hair and scalp, leaving hair soft and nourished.
    Soothe irritated or sensitive scalps: Soothes the scalp to reduce itching, dryness, and inflammation.
    Promoting hair health: Strengthens hair, supports healthy growth, and helps reduce hair breakage.
    Preventing and treating dandruff: Gently exfoliates the scalp to remove dead skin cells, reducing flakiness and preventing dandruff.
    Providing antioxidant protection: Protects the scalp and hair from damage caused by environmental stressors.

  • Warnings

    Warnings:
    For external use only.
    Avoid contact with eyes. In case of contact, rinse immediately with plenty of water. If irritation persists, consult a healthcare professional.
    Do not swallow. If swallowed, seek medical advice immediately or contact a Poison Control Center.
    If irritation or redness develops, discontinue use immediately and consult a healthcare provider. This includes any signs of scalp sensitivity, such as itching, burning, or rash.
    Keep out of reach of children. In case of accidental ingestion, seek medical help right away.
    Do not use if you are allergic to any ingredients listed. If you are unsure, perform a patch test before full use.
    Patch Test Instructions: Apply a small amount of product to the inside of your elbow or behind your ear and wait 24 hours. If irritation, redness, or swelling occurs, do not use the product.
    Use only as directed. Overuse or misuse may lead to scalp dryness or irritation.
    Use caution if you have a sensitive scalp or skin. Some active ingredients (e.g., Tea Tree Oil, Salicylic Acid) may cause mild irritation for those with extremely sensitive skin.
    If pregnant or breastfeeding, consult a healthcare provider before use to ensure the safety of the product for you and your baby.
    Keep the cap tightly closed to prevent contamination. Store in a cool, dry place, away from excessive heat or sunlight.

  • Stop use

    Stop Use and Consult a Doctor If:
    Irritation or redness develops on the scalp or skin, including symptoms like itching, burning, or swelling.
    Severe or persistent scalp irritation occurs after use, such as a rash, blistering, or open sores.
    Eyes become irritated after accidental contact with the shampoo. If irritation persists, seek medical advice.
    Condition worsens or does not improve after using the product regularly.
    Allergic reactions occur, such as hives, difficulty breathing, or swelling of the face, lips, or tongue.
    Excessive dryness or flakiness of the scalp is noticed after use. If this occurs, reduce the frequency of use or discontinue use and consult a healthcare provider.

  • Do not use

    Stop Use and Consult a Doctor If:
    Irritation or redness develops on the scalp or skin, including symptoms like itching, burning, or swelling.
    Severe or persistent scalp irritation occurs after use, such as a rash, blistering, or open sores.
    Eyes become irritated after accidental contact with the shampoo. If irritation persists, seek medical advice.
    Condition worsens or does not improve after using the product regularly.
    Allergic reactions occur, such as hives, difficulty breathing, or swelling of the face, lips, or tongue.
    Excessive dryness or flakiness of the scalp is noticed after use. If this occurs, reduce the frequency of use or discontinue use and consult a healthcare provider.

  • Keep out of reach of children!

    Rationale:
    Accidental ingestion: The presence of ingredients like Tea Tree Oil, Salicylic Acid, and other active botanicals can be harmful if ingested in large amounts. If a child accidentally swallows the shampoo, it may cause gastrointestinal discomfort or other symptoms.
    Children under 2 years of age: Young children have more sensitive skin and are more susceptible to irritation or adverse reactions from certain active ingredients like Tea Tree Oil and Salicylic Acid. It is important to consult a healthcare provider before using such products on children under 2.
    General safety: Since this is a topical product, it's always essential to keep it out of reach of children to avoid any potential misuse or accidental exposure.

  • Precautions for Use

    When Using This Product:
    Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, seek medical attention.
    Do not ingest. If swallowed, contact a Poison Control Center or seek medical help immediately.
    Use only as directed. Excessive use or misuse may cause scalp dryness or irritation.
    If irritation or redness occurs, discontinue use immediately and consult a healthcare provider. This includes itching, burning, or rash on the scalp.
    Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately.
    For external use only. Do not apply to open wounds or broken skin.
    Use with caution if you have sensitive skin. Some ingredients, such as Tea Tree Oil or Salicylic Acid, may cause irritation in individuals with particularly sensitive skin or scalp.
    Do not use more frequently than recommended. Overuse may lead to dryness or scalp irritation.
    Avoid applying to irritated or damaged skin. Use only on healthy, intact scalp and hair.

  • Instructions for Use

    Instructions for Use:
    Wet hair thoroughly with lukewarm water.
    Apply a generous amount of shampoo to your palm. The amount may vary depending on hair length and thickness.
    Massage gently into the scalp and hair, working the shampoo through to the ends. Use your fingertips (not nails) to massage the scalp in circular motions to create a rich lather.
    Leave the shampoo on the scalp for 1-2 minutes to allow the active ingredients to work.
    Rinse thoroughly with lukewarm water, ensuring all shampoo is removed from the hair and scalp.
    For best results, follow with a conditioner that suits your hair type to lock in moisture and enhance the shampoo’s benefits.
    Use regularly for optimal results. For daily use, adjust frequency based on your scalp and hair type. If you have a dry scalp, consider using it every other day or as needed.

  • DOSAGE & ADMINISTRATION SECTION

    Dosage & Administration:
    Amount to Use:
    Dispense a quarter-sized amount (approximately 5–10 mL) of shampoo onto your palm. The exact amount may vary depending on your hair length, thickness, and personal preference.
    Frequency of Use:
    For normal to oily hair/scalp: Use the shampoo 1 to 2 times per week or as needed to cleanse and refresh the scalp and hair.
    For dry or sensitive scalp: Use the shampoo every other day or 2-3 times a week to avoid over-drying the scalp.
    For dandruff or scalp issues: Use the shampoo 2-3 times per week or as directed by a healthcare provider.
    How to Apply:
    Wet hair thoroughly before applying the shampoo.
    Massage gently into the scalp and hair, working the product through to the ends of the hair.
    Allow the shampoo to sit for 1-2 minutes to let the active ingredients work, especially for exfoliating or soothing effects.
    Rinse thoroughly with water.
    Follow-Up: For best results, follow with a conditioner that suits your hair type to lock in moisture and maintain scalp health.

  • PRINCIPAL DISPLAY PANEL

    cgb-141-2

  • INGREDIENTS AND APPEARANCE
    ITSRT TEA TREE OIL AND ARGAN OIL 
    itsrt tea tree oil and argan oil emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84751-097
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF0.1 mg  in 500 mL
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.01 mg  in 500 mL
    ROSEMARY (UNII: IJ67X351P9) (ROSEMARY - UNII:IJ67X351P9) ROSEMARY0.009 mg  in 500 mL
    SORBIC ACID (UNII: X045WJ989B) (SORBIC ACID - UNII:X045WJ989B) SORBIC ACID0.03 mg  in 500 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.15 mg  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    AQUA (UNII: 059QF0KO0R) 7.165 mg  in 500 mL
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84751-097-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03210/01/2024
    Labeler - Guangzhou Qiaoyangzi Cosmetics Technology Co Ltd (705198354)
    Registrant - Guangzhou Qiaoyangzi Cosmetics Technology Co Ltd (705198354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Qiaoyangzi Cosmetics Technology Co Ltd705198354manufacture(84751-097)