SPL v1
SPL
SPL Set ID 37477390-84db-a7c2-e063-6394a90a4aee
Route
TOPICAL
Published
Effective Date 2025-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Butyrospermum Parkii (shea) Butter (0.1 mg) Melaleuca Alternifolia (tea Tree) Leaf Oil Vitis Vinifera (grape) Seed Oil
Inactive Ingredients
Ethylhexylglycerin Fragrance 13576 Phenoxyethanol Tocopherol Cetearyl Alcohol Citric Acid Panthenol Glycerin Stearamidopropyl Dimethylamine Amodimethicone (240 Cst) Dimethiconol (40 Cst) Isopropyl Palmitate Hydroxyethylcellulose Dimethicone Sodium Hyaluronate Argania Spinosa Kernel Oil Butylene Glycol Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-11

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

DIMETHICONE

ISOPROPYL PALMITATE

FRAGRANCE

CITRIC ACID

HYDROXYETHYLCELLULOSE

HYDROLYZED KERATIN

ARGANIA SPINOSA KERNEL OIL

PANTHENOL

TOCOPHEROL

SODIUM HYALURONATE

METHICONE

BUTYLENE GLYCOL

HYDROLYZED WHEAT PROTEIN

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

Section 51945-4

Section 55105-1

Deeply moisturizes hair.

Section 55106-9

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL-----0.1%

BUTYROSPERMUM PARKII (SHEA) BUTTER-----0.1%

VITIS VINIFERA (GRAPE) SEED OIL-----0.1%


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

DIMETHICONE

ISOPROPYL PALMITATE

FRAGRANCE

CITRIC ACID

HYDROXYETHYLCELLULOSE

HYDROLYZED KERATIN

ARGANIA SPINOSA KERNEL OIL

PANTHENOL

TOCOPHEROL

SODIUM HYALURONATE

METHICONE

BUTYLENE GLYCOL

HYDROLYZED WHEAT PROTEIN

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Deeply moisturizes hair.

Section 55106-9 (55106-9)

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL-----0.1%

BUTYROSPERMUM PARKII (SHEA) BUTTER-----0.1%

VITIS VINIFERA (GRAPE) SEED OIL-----0.1%


Advanced Ingredient Data


Raw Label Data

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