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NDC 50268-0682-15 PRAX 10 mg/mL Details

PRAX 10 mg/mL

PRAX is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by AvPAK. The primary component is PRAMOXINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.

Related Packages: 50268-0682-15
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pramoxine

Product Information

NDC	50268-0682
Product ID	50268-682_dc645935-aa50-d07e-e053-2a95a90aa0d7
Associated GPIs	90850065104110
GCN Sequence Number	007423
GCN Sequence Number Description	pramoxine HCl LOTION 1 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	30520
HICL Sequence Number	002977
HICL Sequence Number Description	PRAMOXINE HCL
Brand/Generic	Generic
Proprietary Name	PRAX
Proprietary Name Suffix	n/a
Non-Proprietary Name	pramoxine hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/mL
Substance Name	PRAMOXINE HYDROCHLORIDE
Labeler Name	AvPAK
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2023-12-31

Package

Package Images

NDC 50268-0682-15 (50268068215)

Pricing Information	N/A
NDC Package Code	50268-682-15
Billing NDC	50268068215
Package	237 mL in 1 BOTTLE (50268-682-15)
Marketing Start Date	2022-04-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dc646399-91ba-5cc1-e053-2a95a90a4f9c Details

Active Ingredient

pramoxine HCl 1% w/w

Purpose

local anesthetic

Use

for the temporary relief of discomfort and itch in the perianal area

Warnings

For external use only.

Do not

exceed the recommended daily dosage unless directed by a doctor
put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

condition worsens
symptoms do not improve within 7 days
allergic reactions develop to ingredients in this product
symptom being treated does not subside or if redness, irritation, swelling, pain, bleeding, or other symptoms develop or increase

Keep out of reach of children.

If swallowed, seek medical attention or contact a Poison Control Center right away.

Directions

Shake well before use.
When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
Adults and children 12 years of age and older: apply to affected area up to 5 times daily.
Children under 12 years of age: consult a doctor.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Glycerin, Glyceryl Stearate SE, Mineral Oil, PEG-100 Stearate, Phenoxyethanol, Purified Water, Stearyl Alcohol, White Petrolatum, Xanthan Gum

Package Label

Questions or comments call 1-855-361-3993.

Manufactured for:

AvKARE

Pulaski, TN 38478

www.avkare.com

AV 01/2022

INGREDIENTS AND APPEARANCE

PRAX

pramoxine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50268-682
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
PEG-100 STEARATE (UNII: YD01N1999R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50268-682-15	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/11/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	04/11/2022

Labeler - AvPAK (832926666)

Revised: 4/2022

Document Id: dc645935-aa50-d07e-e053-2a95a90aa0d7

Set id: dc646399-91ba-5cc1-e053-2a95a90a4f9c

Version: 1

Effective Time: 20220411