SPL v1
SPL
SPL Set ID 2e8f9011-178d-f38d-e063-6394a90a8974
Route
TOPICAL
Published
Effective Date 2025-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Rosmarinus Officinalis (rosemary) Leaf Oil (0.001 mg) Melaleuca Alternifolia (tea Tree) Leaf Oil Rosa Damascena Flower Oil
Inactive Ingredients
Cocamidopropyl Betaine Laureth-3 Butylene Glycol Cocos Nucifera (coconut) Oil Paeonia Albiflora Flower Wolfiporia Cocos Whole Trideceth-12 Cetrimonium Chloride Guar Hydroxypropyltrimonium Chloride Butyrospermum Parkii (shea) Butter Menthol Atractylodes Macrocephala Root Sodium Laureth Sulfate Phenoxyethanol Platycladus Orientalis Leaf Aloe Barbadensis Leaf Sodium Cocoamphoacetate Cocamide Mea Polyquaternium-10 (125 Mpa.s At 2%) Edetate Disodium Sodium Chloride Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Tremella Fuciformis Whole Panax Ginseng Whole Ammonium Lauryl Sulfate Dimethiconol (40 Cst) Ethylhexylglycerin Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Caprylyl Glycol Zingiber Officinale (ginger) Root Oil Morinda Citrifolia Seed Oil Glycol Distearate Sodium Lauroyl Sarcosinate Glycol Stearate Polyquaternium-7 Ethanolamine Fragrance 13576 Allantoin Sodium Hydroxide Sodium Carbonate Biotin Panax Ginseng Root Ampelopsis Japonica Root Water Glycerin Amodimethicone (240 Cst) Cocamide Dea Decylene Glycol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-20

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

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

COCAMIDOPROPYL BETAINE

SODIUM CHLORIDE

LAURETH-3

COCAMIDE DEA

GLYCERIN

MORINDA CITRIFOLIA SEED OIL

GLYCOL DISTEARATE

GLYCOL STEARATE

BUTYLENE GLYCOL

HYDROLYZED WHEAT PROTEIN

POLYQUATERNIUM-7

SODIUM COCOAMPHOACETATE

COCAMIDE MEA

ETHANOLAMINE

SODIUM LAUROYL SARCOSINATE

AMODIMETHICONE

TRIDECETH-12

CETRIMONIUM CHLORIDE

DECYLENE GLYCOL

CAPRYLYL GLYCOL

FRAGRANCE

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

ALLANTOIN

GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE

ALOE BARBADENSIS LEAF EXTRACT

BUTYROSPERMUM PARKII (SHEA) BUTTER

COCOS NUCIFERA (COCONUT) OIL

PLATYCLADUS ORIENTALIS LEAF EXTRACT

POLYQUATERNIUM-10

DISODIUM EDTA

SODIUM HYDROXIDE

SODIUM CARBONATE

BIOTIN

PANAX GINSENG ROOT POWDER

ATRACTYLODES MACROCEPHALA ROOT POWDER

TREMELLA FUCIFORMIS (MUSHROOM) EXTRACT

BLETIA HYACINTHINA BULB EXTRACT

PAEONIA ALBIFLORA ROOT EXTRACT

PORIA COCOS EXTRACT

AMPELOPSIS JAPONICA ROOT POWDER

PANAX GINSENG EXTRACT

ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT

MENTHOL

Section 51945-4

Section 55105-1

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

Section 55106-9

ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL -------0.001

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL -------0.001

ROSA DAMASCENA FLOWER OIL -------0.001


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

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

COCAMIDOPROPYL BETAINE

SODIUM CHLORIDE

LAURETH-3

COCAMIDE DEA

GLYCERIN

MORINDA CITRIFOLIA SEED OIL

GLYCOL DISTEARATE

GLYCOL STEARATE

BUTYLENE GLYCOL

HYDROLYZED WHEAT PROTEIN

POLYQUATERNIUM-7

SODIUM COCOAMPHOACETATE

COCAMIDE MEA

ETHANOLAMINE

SODIUM LAUROYL SARCOSINATE

AMODIMETHICONE

TRIDECETH-12

CETRIMONIUM CHLORIDE

DECYLENE GLYCOL

CAPRYLYL GLYCOL

FRAGRANCE

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

ALLANTOIN

GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE

ALOE BARBADENSIS LEAF EXTRACT

BUTYROSPERMUM PARKII (SHEA) BUTTER

COCOS NUCIFERA (COCONUT) OIL

PLATYCLADUS ORIENTALIS LEAF EXTRACT

POLYQUATERNIUM-10

DISODIUM EDTA

SODIUM HYDROXIDE

SODIUM CARBONATE

BIOTIN

PANAX GINSENG ROOT POWDER

ATRACTYLODES MACROCEPHALA ROOT POWDER

TREMELLA FUCIFORMIS (MUSHROOM) EXTRACT

BLETIA HYACINTHINA BULB EXTRACT

PAEONIA ALBIFLORA ROOT EXTRACT

PORIA COCOS EXTRACT

AMPELOPSIS JAPONICA ROOT POWDER

PANAX GINSENG EXTRACT

ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT

MENTHOL

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)

ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL -------0.001

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL -------0.001

ROSA DAMASCENA FLOWER OIL -------0.001


Advanced Ingredient Data


Raw Label Data

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