PROSORIA ANTI-ITCH MOISTURIZER- pramoxine hydrochloride lotion 
Nuvothera, Inc.

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Prosoria Anti-Itch Scalp Moisturizer

Drug Facts

Active ingredient

Pramoxine HCL 1%

Purpose

External analgesic

Use

for the temporary relief of itching associated with minor skin irritations

Warnings

For external use only

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and consult a doctor if

  • the condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

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

Directions

Inactive ingredients

Water, White Petrolatum, Glycerin, PEG-100 Stearate, Glyceryl Stearate SE, Stearic Acid, Copaifera Coriacea Resin Oil, Tetrahydrodiferuloylmethane, Cetyl Alcohol, Stearyl Alcohol, Phenoxyethanol, Vitamin E (Tocopheryl acetate), Xanthan Gum, Sodium Citrate, Disodium EDTA.

Questions?

Visit www.prosoria.com or call toll-free 1-833-776-7483 Mon – Fri, 8am – 5pm CT.

Distributed by Nuvothera, Inc.
Fort Worth, Texas 76104

PRINCIPAL DISPLAY PANEL - 90 mL Bottle Label

moisturizes
relieves itching

prosoriä

anti-itch
moisturizer

Pramoxine Hydrochloride 1%

external analgesic

3 FL OZ (90mL)

Principal Display Panel - 90 mL Bottle Label
PROSORIA ANTI-ITCH MOISTURIZER 
pramoxine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71573-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride0.9 g  in 90 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Cetyl alcohol (UNII: 936JST6JCN)  
COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT)  
Tetrahydrodiferuloylmethane (UNII: 00U0645U03)  
Glyceryl Stearate SE (UNII: FCZ5MH785I)  
PEG-100 STEARATE (UNII: YD01N1999R)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Glycerin (UNII: PDC6A3C0OX)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Xanthan Gum (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71573-120-1190 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM01504/01/2022
Labeler - Nuvothera, Inc. (080499864)
Establishment
NameAddressID/FEIBusiness Operations
Quality CDMO117658386MANUFACTURE(71573-120)

Revised: 1/2024
Document Id: 86c0c7f3-4ba3-4ae2-8f3b-a618dc33eda0
Set id: 3c4b9515-f435-4227-a347-d6508778426d
Version: 2
Effective Time: 20240110
 
Nuvothera, Inc.