Prequel Anti-Itch Solution Medicated Calming

Manufacturer
The Center Brands, LLC
Effective date
2026-03-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:49:18

Label at a glance#

ProductPrequel Anti-Itch Solution Medicated Calming
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure9 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

External Analgesic

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Pramoxine Hydrochloride 1.0%

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Visit prequelskin.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82800-20082800-200

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1246075pramoxine HCl 1 % Topical LotionPSN3
1246075pramoxine hydrochloride 10 MG/ML Topical LotionSCD3
1246075pramoxine hydrochloride 1 % Topical LotionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82800-200-01Prequel Anti-Itch Solution Medicated Calming400 g in 1 TUBELOTION4003

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82800-20082800-200-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-12-04monthly-update2026-06-03 17:45:23
12025-10-20monthly-update2026-06-03 17:39:30

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prequel Anti-Itch Solution Medicated CalmingMEDICATED CALMING LOTIONThe Center Brands, LLC419fa45b-992b-676e-e063-6394a90add812026-03-09WarningsExact identifier
ndc (package): 82800-200-01
ndc (product): 82800-200
ndc11 (package): 82800020001
spl id: 4c9bac93-a769-93fb-e063-6294a90ab661
spl set id: 419fa45b-992b-676e-e063-6394a90add81

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.