PRAX- pramoxine hydrochloride lotion 
AvPAK

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Pramoxine HCl 1% Lotion

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


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

1

PRAX 
pramoxine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-682
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
PETROLATUM (UNII: 4T6H12BN9U)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
MINERAL OIL (UNII: T5L8T28FGP)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PEG-100 STEARATE (UNII: YD01N1999R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50268-682-15237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01704/11/2022
Labeler - AvPAK (832926666)

Revised: 3/2024
Document Id: 13037e04-9836-8184-e063-6394a90a69fc
Set id: dc646399-91ba-5cc1-e053-2a95a90a4f9c
Version: 3
Effective Time: 20240306
 
AvPAK