Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 57c0b71d-6099-415c-976d-b96d2f73e9d3
Route
TOPICAL
Published
Effective Date 2023-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (5.25 mg)
Inactive Ingredients
Water Propanediol Butyrospermum Parkii (shea) Butter Unsaponifiables Undecane Dipentaerythrityl Hexastearate Glycerin Isosorbide Dicaprylate Cetearyl Olivate Silicon Dioxide Phenoxyethanol Ethylhexylglycerin Ceramide Np Cholesterol Phytosphingosine Hydrogenated Soybean Lecithin Centella Asiatica Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Ammonium Acryloyldimethyltaurate/vp Copolymer Hydrogenated Polydecene Type I Xanthan Gum Stearic Acid Hexasodium Phytate Camellia Oleifera Leaf Chamomile Flower Oil Aloe Vera Leaf Citric Acid Acetate Lactic Acid Oleic Acid Laureth-8 Caprylyl Glycol Caprylhydroxamic Acid Tocopherol Potassium Sorbate Sodium Benzoate Sodium Sulfate Tert-butyl Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-30

Description

Skin Protectant

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Skin Protectant

Uses

Temporarily protects and helps releive chafed, chapper or cracked skin

Helps protect fomr the drying effects of wind and cold weather

Warnings

Fox external use only.

When using this product do not get into eyes

Stop use and ask a doctor if condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

Directions

Apply as needed.

Questions?

Visit prequelskin.com

Other Information

• Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place.

Active Ingredients

Dimethicone 5.25%

Inactive Ingredients

Water (Aqua), Propanediol, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Undecane, Glycerin, Dipentaerythryityl Hexahydrostearate/Hexastearate/Hexarosinate, Isosorbate Dicaprylate, Cetearyl Olivate, Tridecane, Sorbitan Olivate, Silica, Ceramide NP, Cholesterol, Phytospingosine, Hydrogentaed Lecithin, Centella Asiatica Extract, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ammonium Acryloyldimethyltuarate/VP Copolymer, Hydrogenated Polydecene, Xanthan Gum, Stearic Acid, Sodium Phytate, Tocopheryl Acetate, Camomilla Recutita Flower Extract, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Ethylhexylglycerin, Citric Acid, Caprylic/Capric Trigylceride, Lactic Acid, Oleic Acid, Laureth-8, Caprylyl Glycol, Caprylhydroxamic Acid, Tocopherol, Potassium Sorbate, Sodium Benzoate, Sodium Sulfate, t-Butyl Acohol

Principal Display Panel

Keep Out of Reach of Children. If Swallowed, Get Medical Help Or Contact A Poison Control Center Right Away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

Temporarily protects and helps releive chafed, chapper or cracked skin

Helps protect fomr the drying effects of wind and cold weather

Purpose

Skin Protectant

Warnings

Fox external use only.

When using this product do not get into eyes

Stop use and ask a doctor if condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

Directions

Apply as needed.

Questions?

Visit prequelskin.com

Other Information

• Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place.

Active Ingredients

Dimethicone 5.25%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Propanediol, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Undecane, Glycerin, Dipentaerythryityl Hexahydrostearate/Hexastearate/Hexarosinate, Isosorbate Dicaprylate, Cetearyl Olivate, Tridecane, Sorbitan Olivate, Silica, Ceramide NP, Cholesterol, Phytospingosine, Hydrogentaed Lecithin, Centella Asiatica Extract, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ammonium Acryloyldimethyltuarate/VP Copolymer, Hydrogenated Polydecene, Xanthan Gum, Stearic Acid, Sodium Phytate, Tocopheryl Acetate, Camomilla Recutita Flower Extract, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Ethylhexylglycerin, Citric Acid, Caprylic/Capric Trigylceride, Lactic Acid, Oleic Acid, Laureth-8, Caprylyl Glycol, Caprylhydroxamic Acid, Tocopherol, Potassium Sorbate, Sodium Benzoate, Sodium Sulfate, t-Butyl Acohol

Principal Display Panel

Keep Out of Reach of Children. If Swallowed, Get Medical Help Or Contact A Poison Control Center Right Away. (Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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