Prequel Anti-itch Solution Medicated Calming Lotion
FDA Label NDC 82800-200

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Center Brands, Llc for the product Prequel Anti-itch Solution Medicated Calming (NDC 82800-200). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding purpose, active ingredients, uses, warnings, keep out of reach of children., directions, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Purpose

External Analgesic

Active Ingredients

Pramoxine Hydrochloride 1.0%

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.

Keep Out Of Reach Of Children.

Keep out of reach of children.

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

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

Questions?

Visit prequelskin.com

Principal Display Panel

82800-200 (82800 200)

82800-200 (82800 200)

* Please review the disclaimer below.