SPL v1
SPL
SPL Set ID 3743b587-9e8d-edc2-e063-6394a90a2981
Route
TOPICAL
Published
Effective Date 2025-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Rosmarinus Officinalis (rosemary) Leaf Oil (0.1 mg) Melaleuca Alternifolia (tea Tree) Leaf Oil Rosa Damascena Flower Oil
Inactive Ingredients
Biotin Edetate Disodium Paeonia Albiflora Flower Glycol Distearate Cocamide Mea Ampelopsis Japonica Root Sodium Carbonate Panax Ginseng Whole Ethylhexylglycerin Atractylodes Macrocephala Root Wolfiporia Cocos Whole Polyquaternium-10 (125 Mpa.s At 2%) C11-15 Pareth-9 Ammonium Lauryl Sulfate Glycerin Amodimethicone (240 Cst) Aloe Barbadensis Leaf Menthol Panax Ginseng Root Water Sodium Laureth Sulfate Sodium Cocoamphoacetate Morinda Citrifolia Seed Oil Laureth-3 Trideceth-12 Ethanolamine Acetic Acid Tremella Fuciformis Whole Cocamidopropyl Betaine Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Dimethiconol (40 Cst) Cocamide Dea Fragrance 13576 Sodium Lauroyl Sarcosinate Guar Hydroxypropyltrimonium Chloride Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Polyquaternium-7 Sodium Hydroxide Platycladus Orientalis Leaf Zingiber Officinale (ginger) Root Oil Allantoin Butyrospermum Parkii (shea) Butter Cocos Nucifera (coconut) Oil Butylene Glycol Glycol Stearate Phenoxyethanol

Identifiers & Packaging

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

Description

Moisturize the hair with warm water. Apply shampoo containing onion, rosemary, and biotin.Massage the scalp gently and continue to rub all over the hair with plenty of water until thoroughly rinsed.


Medication Information

Warnings and Precautions

Keep in a cool, dry place, and protect from moisture and sunlight.

Indications and Usage

Improves the scalp environment, repairs damaged hair, and moisturizes hair. This product contains plant essences to repair the scalp barrier, provide a non-greasy moisturizing effect, and make hair look full and natural.

Dosage and Administration

Moisturize the hair with warm water. Apply shampoo containing onion, rosemary, and biotin.Massage the scalp gently and continue to rub all over the hair with plenty of water until thoroughly rinsed.

Description

Moisturize the hair with warm water. Apply shampoo containing onion, rosemary, and biotin.Massage the scalp gently and continue to rub all over the hair with plenty of water until thoroughly rinsed.

Section 50565-1

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. Keep the bottle closed and store in a cool place.

Section 51727-6

WATER

SODIUM LAURETH SULFATE

AMMONIUM LAURYL SULFATE

DIMETHICONOL

COCAMIDE DEA

GLYCOL DISTEARATE

COCAMIDE MEA

COCAMIDOPROPYL BETAINE

FRAGRANCE

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

ALLANTOIN

GLYCERIN

SODIUM COCOAMPHOACETATE

SODIUM LAUROYL SARCOSINATE

BUTYLENE GLYCOL

GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE

MORINDA CITRIFOLIA SEED OIL

BUTYROSPERMUM PARKII (SHEA) BUTTER

COCOS NUCIFERA (COCONUT) OIL

GLYCOL STEARATE

POLYQUATERNIUM-10

BIS-AMINOPROPYL DIMETHICONE

LAURETH-3

DISODIUM EDTA

HYDROLYZED WHEAT PROTEIN

POLYQUATERNIUM-7

SODIUM HYDROXIDE

PHENOXYETHANOL

C11-15 PARETH-9

TRIDECETH-12

BIOTIN

ALOE BARBADENSIS LEAF EXTRACT

PLATYCLADUS ORIENTALIS LEAF EXTRACT

ETHANOLAMINE

ETHYLHEXYLGLYCERIN

MENTHOL

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL

ROSA DAMASCENA FLOWER OIL

ACETIC ACID

SODIUM CARBONATE

PANAX GINSENG ROOT POWDER

AMPELOPSIS JAPONICA ROOT POWDER

ATRACTYLODES MACROCEPHALA ROOT POWDER

PORIA COCOS EXTRACT

PAEONIA ALBIFLORA ROOT EXTRACT

TREMELLA FUCIFORMIS (MUSHROOM) EXTRACT

BLETIA HYACINTHINA BULB EXTRACT

ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT

PANAX GINSENG EXTRACT

Section 51945-4

Section 55105-1

Improves the scalp environment, repairs damaged hair, and moisturizes hair.

Section 55106-9

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

ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL--------0.1%

ROSA DAMASCENA FLOWER OIL--------0.1%


Structured Label Content

Indications and Usage (34067-9)

Improves the scalp environment, repairs damaged hair, and moisturizes hair. This product contains plant essences to repair the scalp barrier, provide a non-greasy moisturizing effect, and make hair look full and natural.

Dosage and Administration (34068-7)

Moisturize the hair with warm water. Apply shampoo containing onion, rosemary, and biotin.Massage the scalp gently and continue to rub all over the hair with plenty of water until thoroughly rinsed.

Warnings and Precautions (34071-1)

Keep in a cool, dry place, and protect from moisture and sunlight.

Section 50565-1 (50565-1)

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. Keep the bottle closed and store in a cool place.

Section 51727-6 (51727-6)

WATER

SODIUM LAURETH SULFATE

AMMONIUM LAURYL SULFATE

DIMETHICONOL

COCAMIDE DEA

GLYCOL DISTEARATE

COCAMIDE MEA

COCAMIDOPROPYL BETAINE

FRAGRANCE

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

ALLANTOIN

GLYCERIN

SODIUM COCOAMPHOACETATE

SODIUM LAUROYL SARCOSINATE

BUTYLENE GLYCOL

GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE

MORINDA CITRIFOLIA SEED OIL

BUTYROSPERMUM PARKII (SHEA) BUTTER

COCOS NUCIFERA (COCONUT) OIL

GLYCOL STEARATE

POLYQUATERNIUM-10

BIS-AMINOPROPYL DIMETHICONE

LAURETH-3

DISODIUM EDTA

HYDROLYZED WHEAT PROTEIN

POLYQUATERNIUM-7

SODIUM HYDROXIDE

PHENOXYETHANOL

C11-15 PARETH-9

TRIDECETH-12

BIOTIN

ALOE BARBADENSIS LEAF EXTRACT

PLATYCLADUS ORIENTALIS LEAF EXTRACT

ETHANOLAMINE

ETHYLHEXYLGLYCERIN

MENTHOL

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL

ROSA DAMASCENA FLOWER OIL

ACETIC ACID

SODIUM CARBONATE

PANAX GINSENG ROOT POWDER

AMPELOPSIS JAPONICA ROOT POWDER

ATRACTYLODES MACROCEPHALA ROOT POWDER

PORIA COCOS EXTRACT

PAEONIA ALBIFLORA ROOT EXTRACT

TREMELLA FUCIFORMIS (MUSHROOM) EXTRACT

BLETIA HYACINTHINA BULB EXTRACT

ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT

PANAX GINSENG EXTRACT

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Improves the scalp environment, repairs damaged hair, and moisturizes hair.

Section 55106-9 (55106-9)

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

ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL--------0.1%

ROSA DAMASCENA FLOWER OIL--------0.1%


Advanced Ingredient Data


Raw Label Data

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