Prequel Anti-itch Solution Medicated Calming Lotion

Prequel Anti-itch Solution Medicated Calming Lotion
SPL v3
SPL
SPL Set ID 419fa45b-992b-676e-e063-6394a90add81
Route
TOPICAL
Published
Effective Date 2023-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (1 g)
Inactive Ingredients
Ceramide Ap Aloe Barbadensis Leaf Juice Panthenol Phytosphingosine Phenoxyethanol Cholesterol Pentylene Glycol Butylene Glycol Sodium Lauroyl Lactylate Ascorbyl Palmitate .alpha.-tocopherol Acetate, D- Carbomer Polyacrylate Crosspolymer-6 Sodium Stearoyl Glutamate Trisodium Ethylenediamine Disuccinate Potassium Sorbate Sodium Benzoate Chlorphenesin Ethylhexylglycerin Xanthan Gum Anhydrous Citric Acid Glyceryl Stearate Se Cocos Nucifera (coconut) Oil Butyrospermum Parkii (shea) Butter Dimethicone Stearyl Alcohol Propanediol Cetearyl Alcohol Allantoin Water Isopropyl Palmitate Ceramide Np

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-20

Description

External Analgesic

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

External Analgesic

Uses

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritation and rashed ue to poison ivy, poison oak or poison sumac

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

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

Directions

Adulta and children 2 years and older- apply to affected area not more than 3 to 4 times daily. Children under 2 years of age consult a doctor

Questions?

Visit prequelskin.com

Active Ingredients

Pramoxine Hydrochloride 1.0%

Inactive Ingredients

Water, Isopropyl Palmitate, Glyceryl Stearate, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Dimethicone, Cetearyl Aclohol, Stearyl Alcohol, Propanediol, Allantoin, Ceramide NP, Ceramide EOP, Ceramide AP, Aloe Barbadensis Leaf Juice, Panthanol, Phytosphingosine, Cholesterol, Pentylene Glycol, Butylene Glycol, Sodium Lauroyl Lactylate, Hyroxyphenyl Propamidobenzoic Acid, Ascorbyl Palmitate, Tocopheryl Acetate, Tocopherol, Carbomer, Polyacrylate Crosspolymer-6, Sodium Stearoyl Glutamate, Trisodium Ethylenediamine Disuccinate, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Chlorphenesin, Ethylhexylglycerin, Xanthan Gum, Citric Acid

Principal Display Panel

Keep Out of Reach of Children.

Keep out of reach of children.


Structured Label Content

Uses

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritation and rashed ue to poison ivy, poison oak or poison sumac

Purpose

External Analgesic

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

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

Directions

Adulta and children 2 years and older- apply to affected area not more than 3 to 4 times daily. Children under 2 years of age consult a doctor

Questions?

Visit prequelskin.com

Active Ingredients

Pramoxine Hydrochloride 1.0%

Inactive Ingredients (Inactive ingredients)

Water, Isopropyl Palmitate, Glyceryl Stearate, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Dimethicone, Cetearyl Aclohol, Stearyl Alcohol, Propanediol, Allantoin, Ceramide NP, Ceramide EOP, Ceramide AP, Aloe Barbadensis Leaf Juice, Panthanol, Phytosphingosine, Cholesterol, Pentylene Glycol, Butylene Glycol, Sodium Lauroyl Lactylate, Hyroxyphenyl Propamidobenzoic Acid, Ascorbyl Palmitate, Tocopheryl Acetate, Tocopherol, Carbomer, Polyacrylate Crosspolymer-6, Sodium Stearoyl Glutamate, Trisodium Ethylenediamine Disuccinate, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Chlorphenesin, Ethylhexylglycerin, Xanthan Gum, Citric Acid

Principal Display Panel

Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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