PREQUEL ANTI-ITCH SOLUTION MEDICATED CALMING- medicated calming lotion lotion

Prequel Anti-Itch Solution Medicated Calming by

Drug Labeling and Warnings

Prequel Anti-Itch Solution Medicated Calming by is a Otc medication manufactured, distributed, or labeled by The Center Brands, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PREQUEL ANTI-ITCH SOLUTION MEDICATED CALMING 
medicated calming lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82800-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PROPANEDIOL (UNII: 5965N8W85T)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
ALLANTOIN (UNII: 344S277G0Z)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
PANTHENOL (UNII: WV9CM0O67Z)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
CARBOMER (UNII: 0A5MM307FC)
POLYACRYLATE CROSSPOLYMER-6 (UNII: Q7UI015FF9)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CHLORPHENESIN (UNII: I670DAL4SZ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
XANTHAN GUM (UNII: TTV12P4NEE)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82800-200-01	400 g in 1 TUBE; Type 0: Not a Combination Product	10/20/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/20/2025

Labeler - The Center Brands, LLC (076228814)