PROSORIA ANTI-ITCH MOISTURIZER- pramoxine hydrochloride lotion

Prosoria Anti-Itch Moisturizer by

Drug Labeling and Warnings

Prosoria Anti-Itch Moisturizer by is a Otc medication manufactured, distributed, or labeled by Nuvothera, Inc., Quality CDMO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

• adults and children 2 years of age 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, 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.

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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)

INGREDIENTS AND APPEARANCE

PROSORIA ANTI-ITCH MOISTURIZER 
pramoxine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71573-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine Hydrochloride	0.9 g  in 90 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71573-120-11	90 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M015	04/01/2022

Labeler - Nuvothera, Inc. (080499864)

Establishment
Name	Address	ID/FEI	Business Operations
Quality CDMO		117658386	MANUFACTURE(71573-120)