82937-003-08

82937-003-08
SPL v3
SPL
SPL Set ID e76293a8-cbfe-cb77-e053-2995a90a3481
Route
TOPICAL
Published
Effective Date 2023-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (7.0753 g)
Inactive Ingredients
Alpha-tocopherol Acetate Sodium Lactate Caprylhydroxamic Acid Propylene Glycol Glyceryl Stearate/peg-100 Stearate Glycerin Caprylyl Glycol Glycine Glycol Stearate Sodium Lauryl Sulfate Almond Oil Threonine Phenylalanine Histidine Sodium Hydroxide Sodium Pyrrolidone Carboxylate Water Dimethicone 350 Phenoxyethanol Methylpropanediol Tea Tree Oil Pyrrolidone Carboxylic Acid Biotin Pyridoxine Hydrochloride Arginine Isoleucine Limonene, (+)- Isopropyl Myristate Stearyl Alcohol Aloe Vera Leaf Valine Corn Oil Aspartic Acid Alanine Serine Peg-25 Hydrogenated Castor Oil Hamamelis Virginiana Leaf Peppermint Oil Menthol Vitamin A Palmitate Sodium Ascorbyl Phosphate Proline

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-29

Description

Salicylic Acid 3%


Medication Information

Warnings and Precautions

For external use only.

Do not use on broken or inflamed scalp, or on a child under 12 years of age unless directed by a doctor

If you are allergic to ingredients in this product

Indications and Usage

Use reduces and helps eliminate recurrence of flaking and itching associated with dandruff, psoriasis and seborrheic dermatitis.

Dosage and Administration

Dampen hair and apply the scalp treatment mask directly to the scalp in inch partings, gently massage over entire scalp and cover with a shower cap for 20-30 minutes. Remove cap and gently massage scalp for about 5-7 minutes. Rinse, shampoo, condition and style as usual. For best results use at least twice a week or as directed by a doctor.

Description

Salicylic Acid 3%

Section 50565-1

If swallowed, get medical help, or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask doctor

If condition worsens or does not improve after regular use of this product as directed.

Section 50567-7

Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Section 51727-6

Water (Aqua), Propylene Glycol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Glycol Stearate, Isopropyl Myristate, Glyceryl Stearate, PEG-100 Stearate, Sodium Lauryl Sulfate, Stearyl Alcohol, Glycerin, Dimethicone, Caprylhydroxamic Acid, Caprylyl Glycol, Methylpropanediol, Aloe Barbadensis (Aloe Vera) Leaf Juice, Sodium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Hamamelis Virginiana Extract, Mentha Piperita (Peppermint) Oil, Menthol, Biotin, PEG-25 Hydrogenated Castor Oil, Retinyl Palmitate, Sodium Ascorbyl Phosphate, Pyridoxine Hydrochloride, Tocopheryl Acetate, Zea Mays (Corn) Oil, Sodium PCA, Sodium Lactate, Arginine, Aspartic Acid, PCA, Glycine, Alanine, Serine, Valine, Proline, Threonine, Isoleucine, Histidine, Phenylalanine, Phenoxyethanol, Limonene.

Section 55105-1

Anti-dandruff

Anti-psoriasis

Anti-seborrheic dermatitis

Section 55106-9

Salicylic Acid 3%

Section 60561-8

See the top of the tube for lot number and expiration date.

Caribbean Beauty Scalp Treatment Mask


Structured Label Content

Indications and Usage (34067-9)

Use reduces and helps eliminate recurrence of flaking and itching associated with dandruff, psoriasis and seborrheic dermatitis.

Dosage and Administration (34068-7)

Dampen hair and apply the scalp treatment mask directly to the scalp in inch partings, gently massage over entire scalp and cover with a shower cap for 20-30 minutes. Remove cap and gently massage scalp for about 5-7 minutes. Rinse, shampoo, condition and style as usual. For best results use at least twice a week or as directed by a doctor.

Warnings and Precautions (34071-1)

For external use only.

Do not use on broken or inflamed scalp, or on a child under 12 years of age unless directed by a doctor

If you are allergic to ingredients in this product

Section 50565-1 (50565-1)

If swallowed, get medical help, or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask doctor

If condition worsens or does not improve after regular use of this product as directed.

Section 50567-7 (50567-7)

Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Section 51727-6 (51727-6)

Water (Aqua), Propylene Glycol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Glycol Stearate, Isopropyl Myristate, Glyceryl Stearate, PEG-100 Stearate, Sodium Lauryl Sulfate, Stearyl Alcohol, Glycerin, Dimethicone, Caprylhydroxamic Acid, Caprylyl Glycol, Methylpropanediol, Aloe Barbadensis (Aloe Vera) Leaf Juice, Sodium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Hamamelis Virginiana Extract, Mentha Piperita (Peppermint) Oil, Menthol, Biotin, PEG-25 Hydrogenated Castor Oil, Retinyl Palmitate, Sodium Ascorbyl Phosphate, Pyridoxine Hydrochloride, Tocopheryl Acetate, Zea Mays (Corn) Oil, Sodium PCA, Sodium Lactate, Arginine, Aspartic Acid, PCA, Glycine, Alanine, Serine, Valine, Proline, Threonine, Isoleucine, Histidine, Phenylalanine, Phenoxyethanol, Limonene.

Section 55105-1 (55105-1)

Anti-dandruff

Anti-psoriasis

Anti-seborrheic dermatitis

Section 55106-9 (55106-9)

Salicylic Acid 3%

Section 60561-8 (60561-8)

See the top of the tube for lot number and expiration date.

Caribbean Beauty Scalp Treatment Mask (CARIBBEAN BEAUTY - SCALP TREATMENT MASK)


Advanced Ingredient Data


Raw Label Data

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