How Supplied:

How Supplied:
SPL v3
SPL
SPL Set ID 1d666463-8294-5f78-e063-6294a90a91a7
Route
TOPICAL
Published
Effective Date 2024-07-16
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Scartrate™ Cream contains 50 mg of Dimethicone and 22.5 mg of Allantoin per gram in a vehicle consisting of Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis Leaf (Aloe Vera) Juice, Aqua (Purified Water), Butylene Glycol, Carthamus Tinctorius (Safflower) Oil, Cetyl Alcohol, Dimethicone Crosspolymer, Disodium EDTA, DL-alpha Tocopheryl Acetate, GenRx® Complex (proprietary blend), Glycerin, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, sh-Polypeptide-121, Sodium Hydroxide, Stearic Acid, and Fragrance.


Medication Information

Indications and Usage

Scartrate™ Cream is indicated for temporary protection and relief of chapped or cracked skin, it also effectively reduces the overall appearance of scars.

Dosage and Administration

After cleansing, apply Scartrate™ Cream evenly to the affected area until it blends into the skin. Do not rinse off. Recommended for use in the morning (AM) and evening (PM). Reapply as needed to maintain skin protection and moisture.

Dosage Forms and Strengths

Scartrate™ Cream is supplied in a 3 oz (85 g) tube (NDC 59088-326-07) with CRC Cap. Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]. Keep container tightly closed. Use under the direction of a licensed healthcare practitioner. Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873.

Contraindications

Do not use on deep or puncture wounds, animal bites, or serious burns.

Description

Scartrate™ Cream contains 50 mg of Dimethicone and 22.5 mg of Allantoin per gram in a vehicle consisting of Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis Leaf (Aloe Vera) Juice, Aqua (Purified Water), Butylene Glycol, Carthamus Tinctorius (Safflower) Oil, Cetyl Alcohol, Dimethicone Crosspolymer, Disodium EDTA, DL-alpha Tocopheryl Acetate, GenRx® Complex (proprietary blend), Glycerin, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, sh-Polypeptide-121, Sodium Hydroxide, Stearic Acid, and Fragrance.

Section 34084-4

No adverse reactions have been reported under normal conditions of use. If you experience any unusual reactions, discontinue use and consult your licensed healthcare practitioner.

Section 43684-0

Not specifically tested for use in pregnant or nursing women, children, or the elderly. Use caution and consult a licensed healthcare practitioner if you belong to one of these populations.

Section 43685-7

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. For external use only. Avoid contact with eyes. If the condition worsens, stop use and consult a licensed healthcare practitioner.

Section 51945-4

Manufactured by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873


Structured Label Content

Indications and Usage (34067-9)

Scartrate™ Cream is indicated for temporary protection and relief of chapped or cracked skin, it also effectively reduces the overall appearance of scars.

Dosage and Administration (34068-7)

After cleansing, apply Scartrate™ Cream evenly to the affected area until it blends into the skin. Do not rinse off. Recommended for use in the morning (AM) and evening (PM). Reapply as needed to maintain skin protection and moisture.

Dosage Forms and Strengths (34069-5)

Scartrate™ Cream is supplied in a 3 oz (85 g) tube (NDC 59088-326-07) with CRC Cap. Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]. Keep container tightly closed. Use under the direction of a licensed healthcare practitioner. Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873.

Contraindications (34070-3)

Do not use on deep or puncture wounds, animal bites, or serious burns.

Section 34084-4 (34084-4)

No adverse reactions have been reported under normal conditions of use. If you experience any unusual reactions, discontinue use and consult your licensed healthcare practitioner.

Description (34089-3)

Scartrate™ Cream contains 50 mg of Dimethicone and 22.5 mg of Allantoin per gram in a vehicle consisting of Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis Leaf (Aloe Vera) Juice, Aqua (Purified Water), Butylene Glycol, Carthamus Tinctorius (Safflower) Oil, Cetyl Alcohol, Dimethicone Crosspolymer, Disodium EDTA, DL-alpha Tocopheryl Acetate, GenRx® Complex (proprietary blend), Glycerin, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, sh-Polypeptide-121, Sodium Hydroxide, Stearic Acid, and Fragrance.

Section 43684-0 (43684-0)

Not specifically tested for use in pregnant or nursing women, children, or the elderly. Use caution and consult a licensed healthcare practitioner if you belong to one of these populations.

Section 43685-7 (43685-7)

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. For external use only. Avoid contact with eyes. If the condition worsens, stop use and consult a licensed healthcare practitioner.

Section 51945-4 (51945-4)

Manufactured by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873


Raw Label Data

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