PRAX- pramoxine hydrochloride lotion

PRAX by

Drug Labeling and Warnings

PRAX by is a Otc medication manufactured, distributed, or labeled by AvPAK. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50268-682-15	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/11/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/11/2022

Labeler - AvPAK (832926666)