SPL v1
SPL
SPL Set ID 2f06bef8-257f-6a40-e063-6294a90a481f
Route
TOPICAL
Published
Effective Date 2025-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Vitis Vinifera (grape) Seed Oil (0.11 mg) Melaleuca Alternifolia (tea Tree) Leaf Oil Butyrospermum Parkii (shea) Butter
Inactive Ingredients
Glycerin Dimethicone Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Water Fragrance 13576 Tocopherol Cetearyl Alcohol Stearamidopropyl Dimethylamine Methicone (20 Cst) Citric Acid Hydrolyzed Sheep Wool Keratin (200 Mw) Panthenol Argania Spinosa Kernel Oil Phenoxyethanol Butylene Glycol Hydroxyethylcellulose Sodium Hyaluronate Isopropyl Palmitate Ethylhexylglycerin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-26

Description

After shampooing, apply an appropriate amount of conditioner to the hair gently massage - for 2-3 minutes, and then rinse off with clean water.


Medication Information

Warnings and Precautions

Keep out of the reach of children. Avoid contact with the eyes. If you observe an unfavorable reaction, suspend use and, if it persists, consult a doctor.

Indications and Usage

Deeply moisturizes hair. When used with Biotin Shampoo, it helps improve dryness, repair damage,and reduce split ends and breakage.

Dosage and Administration

After shampooing, apply an appropriate amount of conditioner to the hair gently massage - for 2-3 minutes, and then rinse off with clean water.

Description

After shampooing, apply an appropriate amount of conditioner to the hair gently massage - for 2-3 minutes, and then rinse off with clean water.

Section 50565-1

Keep out of the reach of children.

Section 51727-6

WATER

GLYCERIN

CETEARYL ALCOHOL

STEARAMIDOPROPYL DIMETHYLAMINE

BIS-AMINOPROPYL DIMETHICONE

HYDROLYZED KERATIN

METHICONE

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

DIMETHICONE

ISOPROPYL PALMITATE

FRAGRANCE

CITRIC ACID

HYDROXYETHYLCELLULOSE

BUTYLENE GLYCOL

HYDROLYZED WHEAT PROTEIN

PANTHENOL

SODIUM HYALURONATE

ARGANIA SPINOSA KERNEL OIL

TOCOPHEROL

Section 51945-4

Section 55105-1

Deeply moisturizes hair.

Section 55106-9

BUTYROSPERMUM PARKII (SHEA) BUTTER--------0.11%

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL--------0.11%

VITIS VINIFERA (GRAPE) SEED OIL--------0.11%


Structured Label Content

Indications and Usage (34067-9)

Deeply moisturizes hair. When used with Biotin Shampoo, it helps improve dryness, repair damage,and reduce split ends and breakage.

Dosage and Administration (34068-7)

After shampooing, apply an appropriate amount of conditioner to the hair gently massage - for 2-3 minutes, and then rinse off with clean water.

Warnings and Precautions (34071-1)

Keep out of the reach of children. Avoid contact with the eyes. If you observe an unfavorable reaction, suspend use and, if it persists, consult a doctor.

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 51727-6 (51727-6)

WATER

GLYCERIN

CETEARYL ALCOHOL

STEARAMIDOPROPYL DIMETHYLAMINE

BIS-AMINOPROPYL DIMETHICONE

HYDROLYZED KERATIN

METHICONE

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

DIMETHICONE

ISOPROPYL PALMITATE

FRAGRANCE

CITRIC ACID

HYDROXYETHYLCELLULOSE

BUTYLENE GLYCOL

HYDROLYZED WHEAT PROTEIN

PANTHENOL

SODIUM HYALURONATE

ARGANIA SPINOSA KERNEL OIL

TOCOPHEROL

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Deeply moisturizes hair.

Section 55106-9 (55106-9)

BUTYROSPERMUM PARKII (SHEA) BUTTER--------0.11%

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL--------0.11%

VITIS VINIFERA (GRAPE) SEED OIL--------0.11%


Advanced Ingredient Data


Raw Label Data

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